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No data protection officer was appointed, as there is no obligation to appoint a data protection officer according to Art. 37(1) GDPR.
In principle, we process the personal data of our users only if doing so is required in order to ensure that our website functions properly and to the extent necessary for our online products and services. As a rule, personal data of our users is processed only with the consent of the user, with the exception of cases in which it is not possible to obtain prior consent for factual or practical reasons and the data processing is permissible by law.
Art. 6(1)(a) EU General Data Protection Regulation (GDPR) serves as the legal basis in the event that we obtain the consent of the data subject for personal data processing operations.
Art. 6(1)(b) GDPR forms the legal basis in cases where processing of personal data is required for the performance of a contract, to which the data subject is a contractual party. This also applies to processing operations that are necessary to take steps prior to entering into a contract.
Art. 6(1)(c) GDPR serves as legal basis insofar as the processing of personal data is required for compliance with a legal obligation, to which our company is subject.
In the event that vital interests of the data subject or another natural person render the processing of personal data necessary, Art. 6(1)(d) GDPR becomes the legal basis.
Art. 6(1)(f) GDPR serves as legal basis for processing personal data if it is required to protect a legitimate interest of our company or a third party and if the said interest is not overridden by the interests, fundamental rights and freedoms of the data subject.
Personal data of the data subject are erased or blocked as soon as the intended purpose of saving the data ceases to apply. Personal data may remain stored if it has been stipulated by the European or national legislative authority in the EU provisions, laws or other regulations to which the controller is subject. Data are also blocked or erased in the event that the storage period stipulated by said regulations expires, unless the data need to continue to be stored for the purposes of concluding or performing a contract.
You may acquire usage rights to our software products in our online shop.
The data are stored in our system. This excludes payment information (credit card information as well as PayPal information), which we do not store. The IP address of the user, or any other data that allow allocation of the data to a specific user, are not saved. These data are not stored with other personal data of the user.
Art. 6(1)(a) GDPR forms the legal basis for the processing of data where consent of the user is available.
Additional legal basis for the processing of data is Art. 6(1)(b) GDPR.
Data must be collected for the purpose of performing the contract concluded with the user.
The data are erased once collection thereof is no longer required to achieve the purpose for which such data were being collected.
With respect to data collected during the ordering process for contract performance or for steps taken prior to entering into a contract collection is no longer required if the data are no longer needed to execute the contract. It may be necessary to store the personal data of the contractual partner even after conclusion of the contract to remain in compliance with contractual or legal obligations.
As a user you have the option to cancel your registration at any time. At any point of time, you may have the data stored on you rectified.
Should the data be required for performance of a contract or for taking steps prior to entering into a contract, a premature erasure of the data is only possible if no contractual or legal obligations contradict such erasure.
Each time you visit our website, our system automatically collects data and information on the calling computer system.
These data are also stored in the log files of our system. The IP address of the user, or any other data that allows allocation of the data to a specific user, are not saved. These data are not stored with other personal data of the user.
Art. 6(1)(f) GDPR forms the legal basis for the temporary storage of data.
The temporary storage of the IP address by the system is necessary to enable delivery of the website to the user’s computer. For this purpose, the IP address of the user must remain stored for the duration of the session.
Our legitimate interest in data processing in accordance with Art. 6(1)(f) GDPR is also inherent in this purpose.
Access log files are archived by DigiPara for 60 days and then erased.
Collecting data to make the website available and the storing of data in log files is absolutely necessary for website operation. Therefore, the user does not have the option of objection.
(1) This website uses Google Analytics, a web analysis service of Google Inc. («Google»). Google Analytics uses so-called “cookies”, which are text files that are saved on your computer and allow your use of the website to be analysed. The information generated by the cookie regarding your use of this website is usually transferred to Google’s server in the USA and stored there. In the event that IP-anonymisation is activated on this website, your IP address will first be truncated by Google within Member States of the European Union or in any other contracting states of the Agreement on the European Economic Area. Only in exceptional cases is the full IP address transmitted to a Google server in the USA and truncated there. Google uses this information on behalf of the operator of this website to evaluate your use of the website, compile reports on the website activities and provide additional services associated with the use of the website and the Internet to the website operator.
(3) You can prevent cookies from being stored on your computer by selecting the appropriate settings on your browser; however, please note that if you do this, you may not be able to make full use of all the features of this website. Furthermore, you can prevent Google from collecting the data generated by the cookie and related to the usage of the website (including your IP address) and from processing such data by downloading and installing the browser plugin which is available at: https://tools.google.com/dlpage/gaoptout?hl=en.
(4) This website uses Google Analytics with the “_anonymizeIp()” extension. It processes IP addresses further in truncated form, making it impossible to trace the IP address back to a specific person. Therefore, if the data collected on you has any reference to personal identification, it will be immediately excluded and the personal data will be promptly deleted.
(5) We use Google Analytics so that we can analyse the usage of our website and to regularly improve it. Using the statistics we obtain, we can improve our service and make it more interesting to you as a user. In exceptional cases, where personal data are transmitted to the USA, Google adheres to the requirements of the EU-US Privacy Shield, https://www.privacyshield.gov/EU-US-Framework. Art. 6(1), cl. 1 of (f) GDPR serves as the legal basis for the use of Google Analytics.
Art. 6(1)(f) GDPR forms the legal basis for using technically required cookies to process personal data.
Art. 6(1)(a) GDPR forms the legal basis for using cookies to process personal data for analysis purposes where the user has granted consent.
User data collected by means of technically required cookies is not used to create user profiles.
Analysis cookies are used only for one purpose: to improve the quality of our website and improve its contents. Through analysis cookies we learn how the website is used and, can thus continually optimise our service.
Our legitimate interest in processing personal data in accordance with Art. 6(1)(f) GDPR is also inherent in this purpose.
The user’s consent to the processing of these data are obtained as part of the registration process.
Art. 6(1)(b) GDPR serves as the additional legal basis where the registration is for the purpose of contract performance, to which the user is a contractual party, or for steps taken prior to entering into a contract.
In addition, user registration is required for the purpose of contract performance with the user or for steps taken prior to entering into a contract. User registration is also necessary to be able to complete orders in the shop area or to send support requests.
The data are erased once its collection is no longer required to achieve the purpose for which such data were being collected.
With respect to data collected during the registration process for contract performance or for steps taken prior to entering into a contract collection is no longer required if the data are no longer needed to execute the contract. It may be necessary to store the personal data of the contractual partner even after conclusion of the contract to remain in compliance with contractual or legal obligations.
As a user you have the option to cancel your registration at any time. At any point in time, you may have the data stored on you rectified.
Art. 6(1)(b) GDPR forms the legal basis.
The collection of data is necessary for use of the software provided by us and it serves the purpose of performing a contract with the user.
Should the data be required for performing a contract or for taking steps prior to entering into a contract, a premature erasure of the data is only possible if no contractual or legal obligations contradict such erasure.
Alternatively, it is also possible to get in touch via the email address provided. In this case, the user’s personal data that were transmitted in the email are stored.
In this context, the data are not shared with third parties. The data are used exclusively for processing the conversation.
Art. 6(1)(a) GDPR forms the legal basis for the processing of data in the case where the consent of the user is available.
The legal basis for processing the data that is transmitted while sending an email is Art. 6(1)(f) GDPR. In case contact by email is made for the purpose of concluding a contract, then Art. 6(1)(b) GDPR serves as the additional legal basis.
The personal data from the input screen is processed for the sole purpose of facilitating communication. If contact is made by email, a necessary legitimate interest in the processing of the data also applies here.
Other personal data processed during the sending procedure help to prevent misuse of the contact form and ensure the safety of our IT systems.
The data are erased once collection thereof is no longer required to achieve the purpose for which such data were being collected. With respect to personal data from the input screen of the contact form and such that was transmitted to us by email, this is the case once the conversation with the user has ended. The conversation is deemed to have ended when it can be inferred from the circumstances that the relevant facts have been conclusively clarified.
Any additional personal data collected during the sending procedure is erased no later than after a period of seven days.
The user has the option at all times to withdraw his/her consent to the processing of the personal data. If the user contacts us via email, he or she may object to the storage of their personal data at any time. In such a case, the conversation may not be pursued further.
The objection is to be sent to the following email address: info@digipara.com.
All personal data stored in the course of the communication is erased in this case.
For a standardised display of fonts, this website uses so-called web fonts provided by Google. When you visit a page, your browser loads the required web fonts into your browser cache in order to display texts and fonts correctly.
This website uses the Google Maps service via an API. The provider is Google Inc., 1600 Amphitheatre, Parkway, Mountain View, CA 94043, USA.
Your IP address must be stored in order for the Google Maps features to function properly. This information is usually transferred to a Google server in the USA and stored there. The provider of this website has no influence on this data transfer.
You have the right to obtain a confirmation from the controller as to whether personal data concerning you is being processed by us.
(8) the existence of an automated decision-making process, including profiling, pursuant to Art. 22(1) and (4) GDPR and – at least in these cases – conclusive information on the logic involved, as well as the importance and intended consequences of such processing for the data subject.
You are entitled to request information as to whether the personal data concerning you are transmitted to a third country or an international organisation. In this regard, you may also ask to be informed about the appropriate safeguards according to Art. 46 GDPR relating to such transmission.
If the processed personal data concerning you are incorrect or incomplete, you have the right to demand rectification and/or completion of the data from the controller. The controller is obliged to perform such rectification without undue delay.
(4) if you have objected to the processing of your data pursuant to Art. 21(1) GDPR and it is not yet certain whether the legitimate reasons of the controller override your reasons.
If the processing of your personal data has been restricted, then these data – except for its storage – may be processed only with your consent or for the establishment, exercising or defence of legal claims or to protect the rights of another natural person or legal entity or for reasons of important public interest of the Union or of a Member State.
If the restriction on processing is effected in accordance with the above-mentioned conditions, you will be informed by the controller before this restriction is removed.
(6) your personal data was collected in connection with the offered services of the information society pursuant to Art. 8(1) GDPR.
If the controller has made your personal data public and is obliged to erase it in accordance with Art. 17(1) GDPR, then the controller, taking account of the available technology and the cost of implementation, shall take reasonable steps, including technical measures, to inform the controllers processing the personal data that you as data subject have requested the erasure by such controllers of all links to, or copy or replication of, this personal data.
If you have asserted the right to rectification, deletion or restriction of processing vis-à-vis the controller, then the controller is obliged to inform all recipients, to whom your personal data has been disclosed, about this rectification or deletion of data or the restriction on processing, unless this proves impossible or involves disproportionate effort.
You are entitled to request information from the controller about these recipients.
(2) the processing is done using automated processes.
In exercising this right you are further entitled to have your personal data transmitted directly from one controller to another, as long as it is technically feasible. This may not negatively affect the rights and freedoms of any other person.
The right to data portability does not apply to the processing of personal data required for performing a task in the public interest or as part of exercising public authority vested in the controller.
You are entitled to object at any point in time to the processing of your personal data on the basis of Art. 6(1)(e) or (1)(f) GDPR on grounds relating to your particular situation; this also applies to profiling based on these provisions.
If your personal data are being processed for direct advertising, then you have the right to object at any point in time to the processing of personal data concerning you for such advertising purposes; this also applies to profiling, provided it is related to such direct advertising.
If you object to the processing for purposes of direct advertising, your personal data will no longer be processed for such purposes.
Regardless of the Directive 2002/58/EC, you have the option, in the context of the use of information society services, of exercising your right to object through automated procedures using technical specifications.
You have the right to withdraw your consent declaration under data protection law at any time. The withdrawal of consent does not affect the legality of the processing on the basis of consent until the time of its withdrawal.
However, these decisions may not be based on special categories of personal data as per Art. 9(1) GDPR, provided Art. 9(2)(a) or (2)(g) GDPR does not apply and appropriate measures have been taken to protect the rights and freedoms as well as your legitimate interests.
In the cases referred to in (1) and (3), the controller shall take appropriate measures to safeguard the rights and freedoms as well as your legitimate interests, such that there exists at least the right to obtain human intervention on part of the controller, to present a personal point of view and to contest the decision.
Without prejudice to any other administrative or judicial remedy, you are entitled to lodge a complaint with a supervisory authority – in particular in the Member State of your residence, your place of work or the place of the alleged violation – if you are of the view that the processing of your personal data is in violation of GDPR.
The supervisory authority, with whom the complaint has been lodged, shall inform the complainant on the progress and the outcome of the complaint, including the possibility of legal remedy pursuant to Art. 78 GDPR.

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22. Snell v. Harrison, 131 Mo. 495, 52 Am. St. Rep. 642, 32 S. W. 37, overruling Mabary v. Dollarhide, 98 Mo. 204, 14 Am. St. Rep. 639, 11 S. W. 611: Rogers v. Johnson, 259 Mo. 173, 168 S. W. 613; Perry v. Eagle Coal Co., 170 Ky. 824. 186 S. W. 875, apparently overruling Mar-tin v. Hall,. 152 Ky. 677. 153 S. W. 997; Brolaskey v. Mcclain, 61 Pa. St. 166; Wade v. Mc Dougle, 59 W. Va. 113, 52 S. E. 1026.
A like view has been taken as to the effect of a decree for a conveyance (Gower v. Quinlan, 40 Mich. 572) and a decree quieting title (Hintrager v. Smith, 89 Iowa. 270, 56 N. W. 456; Oberein v. Wells, 163 I11. L01, 16 N. E, 294).
23. Kennedy v Reynolds, 27 Ala. 364; Smith v. Hornback, 4 Litt. 233; Jack on v. Haviland, 13 Johns. 229.
24. See an excellent editorial note in 9 Columbia Law Rev. at p. 351.
25. 9 Columbia Law Rev. 351.
27. See Sanford v. Herron, 161 Mo. 176, 84 Am. St. Rep. 703, 61 S. W. 839.
28. Ross v. Goodwin, 88 Ala. 390, 6 So. 682; Brown v. Hanauer, 48 Ark. 277, 3 S. W. 27; Town-send v. Edwards, 25 Fla. 582. 6 So. 212; Chicago & A. R. Co. v. Keegan, 185 111. 70, 56 N. E. 1088; Steeple v. Downing, 60 Ind. 478; Logan v. Williams, 159 Ky. 412, 167 S. W. 124; Armstrong v. Risteau's Lessee, 5 Ind. 256, 59 Am. Dec. 115; Old South Soc. v. Wainwright, 156 Mass. 115, 30 N. E. 476; Bliss v. Johnson, 94 N. Y. 235; Philipson v. Flynn.
83 Tex. 580, 19 S. W. 136; Hlinois Steel Co. v. Budzisz, 115 Wis. 68, 90 N. W. 1019.
29. Louisville & N. R. Co. v. Philyaw, 88 Ala. 264, 6 So. 837; Sharp v. Johnson, 22 Ark. 79; Clark v. White, 120 Ga. 957, 48 S. E. 357: Downing v. Mays, 153 111. 33, 46 Am. st. Rep. 896, 38 N. E. 620: Nixon v. Porter, 38 Miss. 101: Barrell v. Title Guarantee & Trust Co. 2,7 Ore. 77. 39 Pac. 997: Stephens v. Leach, 19 Pa. st 262; Fitch v Boyer, 51 Tex. 336.

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Assisted clients in navigating complex regulatory issues before many state and federal agencies, including the Agency for Health Care Administration, the Department of Health, the Centers for Medicare and Medicaid Services, the Department of Revenue, the Department of Education, and the Department of Transportation.
Represented hospitals, trauma centers, hospices, physicians, durable medical equipment providers, and other health care providers in numerous regulatory and litigation matters involving a wide-range of subjects (e.g., licensure; trauma center designation or verification; certificates of need, Medicaid; Medicare; fraud, abuse and compliance).
Represented both vendors and state agency clients in contract procurements and bid protests involving some of the largest public contracts in Florida.
Represented insurance companies in state premium tax audits.
Shands Jacksonville Medical Center, Inc. v. Department of Health, 123 So. 3d 86 (Fla. 1st DCA 2013) (represented Tampa General Hospital and Bayfront Medical Center in administrative litigation over proposed trauma centers).
Department of Health v. Bayfront Medical Center, Inc., 134 So. 3d 1024 (Fla. 1st DCA 2012) (represented Tampa General Hospital and Bayfront Medical Center in rule challenge involving the Department of Health’s trauma center need rule).
Siegers Seed Co. v. Williams Farm Partnership, 17 So. 3d 848 (Fla. 1st DCA 2009).
General Electric Co. v. Department of Transportation, 869 So. 2d 1273 (Fla. 1st DCA 2004) (bid protest).
Department of Education v. Cooper, 858 So. 2d 394 (Fla. 1st DCA 2003) (filed amici curiae brief on behalf of Harcourt Educational Measurement and the Association of Test Publishers supporting the position of the Department of Education).
Department of Lottery v. Gtech Corp., 816 So. 2d 648 (Fla. 1st DCA 2001) (representation of the Department of Lottery in litigation involving the on-line gaming contract).
Lawnwood Medical Center, Inc. v. Agency for Health Care Administration, 678 2d 421 (Fla. 1st DCA 1996) (successfully represented applicant seeking a certificate of need for a proposed open heart surgery program).
Ball v. Florida Podiatrist Trust, 620 So. 2d 1018 (Fla. 1st DCA 1993).
Sun City Hospital, Inc. v. Agency for Health Care Administration, Case No. 08-0614 (Fla. AHCA December 3, 2011; Fla. DOAH August 8, 2011) (successfully opposed issuance of certificate of need for a proposed replacement hospital).
Auto-Owners Insurance Co. v. Department of Revenue, Case No. 08-CA-1938, 2nd Judicial Circuit, Leon County, Florida (successful circuit court challenge to a premium tax audit in which the Department of Revenue had denied a salary tax credit for bonuses paid to Florida employees of the insurer).
Affiliated Computer Services, v. Agency for Health Care Administration and EDS Information Services, LLC, Case No. 05-3676BID (Fla. AHCA March 3, 2006; Fla. DOAH January 17, 2006), per curium aff’d, Case No. 1D06-1104 (Fla. 1st DCA 2007) (successfully defended Electronic Data Systems and its award of a $308 million contract by AHCA to design, build and operate a Medicaid Management Information System).
Unisys Corp. v. Department of Children and Family Services, Case 05-3144BID (Fla. DCF February 21, 2006; Fla. DOAH February 2, 2006) (successfully defended agency in bid protest that challenged agency’s decision in awarding a $100 million contract for programming and support services for the Florida Online Recipient Integrated Data Access System).
Carl J. Ferro and Italia, Inc. v. Florida Windstorm Underwriting Association, Case 14808(14), 17th Judicial Circuit, Broward County, Florida (obtained order denying motion seeking class certification).
Cigna Dental Health of Florida, Denticare, Inc., Protective Life Insurance Co., and American Dental Plan, Inc. v. Department of Management Services, Case No. 99-2973, 2nd Judicial Circuit, Leon County, Florida (obtained preliminary injunction for plaintiff insurance plans that prevented the state of Florida from terminating plaintiffs’ right to offer their plans to state employees).

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Available March 26, 2019, a new course “FDA and Prescription Drugs: Current Controversies in Context” will be offered at no cost via the HarvardX online platform (part of the non-profit EdX consortium). It is designed around a 6-week, self-paced schedule, and features expert guest speakers including former FDA commissioner Margaret Hamburg.
Earlier this week the Supreme Court heard oral arguments in FTC v. Actavis, in which the Federal Trade Commission is asserting that it is impermissible for a brand name drug company to pay a generic drug company to stay out of the market. Normally, such collusive behavior would constitute a clear violation of antitrust laws, because it reduces competition and thereby has the potential to raise prices to the detriment of consumers. But a complication arises in the case of branded and generic drugs because a patent is involved, giving the patent holder the lawful right to exclude competitors from the marketplace.
In a typical “reverse payment” case, the scenario unfolds as follows: First, the branded company enters the market with a new drug product that is covered by a patent. Some time later, but before the expiration of the patent, a generic drug company seeks to market a generic version of a drug, asserting that the patent is either invalid or not infringed (the assertion takes the form of a Paragraph IV certification, named for the section of the U.S. statute under which the certification arises, see 21 U.S.C. 355(j)(2)(A)(vii)(IV)). Rather than litigate the case to completion, however, the two firms settle, with the patent holder agreeing to pay the generic company to stay off the market until some future date, such as the date that the patent is set to expire. The “monopoly” profits are thus shared between the two companies, to the detriment of consumers.
Xolair for Chronic Itch: Magic Bullet or Marketing Hype?
Earlier this week, the New York Times reported that Xolair (omalizumab), a monoclonal antibody approved in 2003 to treat allergic asthma, had recently shown efficacy in relieving hives patients of chronic itch (See Laurie Tarkan, Drug to Treat Asthma Could Relieve Hives Patients of a Chronic Itch, Study Says, N.Y. Times, Feb. 25, 2013, at A5). The article noted that a Phase 3 trial (usually, the final phase before FDA approval) showed that a monthly injection of Xolair “significantly reduced hives and itchiness.” Quoting the lead author of the study, the article reported that Xolair “is the magic bullet patients have been waiting for for the last 40 years.” Is it?
An initial concern is the large number of conflicts of interest associated with the study. An examination of the Phase 3 trial as published in the New England Journal of Medicine (NEJM), on which the New York Times article is based, reveals that the trial was “[f]unded by Genentech and Novartis,” both of which sell Xolair. The lead author and at least one other co-author of the study have received consulting fees from one or both companies, while another of the co-authors (Karin Rosen) is the medical director for Genentech. Conflicts of interest, however, do not necessarily mean that the drug is in fact ineffective. To determine efficacy, one must look at the evidence.
An earlier post discussed the equivocal efficacy of Propecia (finasteride) as a baldness remedy, ending with the provocative assertion that, efficacy aside, “there is little reason for anyone ever to buy or consume Propecia (finasteride), or any doctor ever to prescribe it, since a much cheaper and identical chemical sold under the trade name Proscar (finasteride), is available.” This post continues the discussion, addressing one small component of the rising cost of healthcare—the cost of finasteride. It explores why consumers pay as much as $240 for a bottle of Propecia (finasteride) when a $9 bottle of an equivalent, FDA-approved supply of the identical chemical is readily and legally available at nearby stores.
Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?
Questionable baldness remedies have been peddled since the beginning of medicine. According to Pliny (23-79 A.D.), ashes of seahorse could cure baldness. Almost 2000 years later, the British Medical Association warned the public of the increasing “number of preparations put forward for the cure of baldness,” particularly those which “are not applied locally but taken internally.” The purported active ingredient? “[H]aemoglobin.” (see Secret Remedies (1909), page 114).
While the medicinal use of a seahorse or dried blood matter may sound fanciful to modern ears, one has to wonder whether today’s public is any less credulous: Worldwide, consumers have spent over $400 million per year on a modern baldness remedy known by the trade name Propecia (finasteride). Has science finally triumphed over a medical condition that has persisted through millennia? Today’s consumers might rationally believe that its has, given that Propecia is FDA-approved for the treatment of alopecia (baldness). FDA-approved remedies must, according to federal law (21 U.S.C. § 355(d)), prove their efficacy in well-controlled, clinical investigations.
At $28,000 a Dose, How Effective Is Acthar?
In a well-researched, recent post, Patrick O’Leary addresses the FDA’s efficacy requirements as applied to an old drug, Acthar (corticotropin), that was first approved in 1952 and granted an orphan designation in 2010 for the treatment of infantile spasms. The initial approval therefore occurred before the Drug Amendments of 1962, which instituted a “new” statutory requirement of efficacy (more on this below). O’Leary points out that Acthar’s “grandfather” status does not entirely exempt it from the FDA’s efficacy requirements, and that the drug did survive an efficacy evaluation under the DESI program. But how effective is Acthar?
Until recently, most ordinary people had never heard of “pharmacy compounding.” Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis Outbreak, N.Y. Times, Oct. 6, 2012).
Compounding is the practice of preparing a drug for an individual patient’s needs, and is used when those needs cannot be met by a mass-produced drug. See Thompson v. Western States Medical Center, 535 U.S. 357, 360 (2002). For example, if a patient is allergic to a particular excipient (inactive ingredient) in an FDA-approved medicine, a doctor may order a special compounding pharmacy to prepare the medicine without that excipient. Because of the very small scale of compounding, Congress in 1997 attempted to exempt (via 21 U.S.C. § 353a) the industry from a number of provisions of the Food Drug and Cosmetic Act, including the requirement to submit a new drug application prior to interstate sale (21 U.S.C. § 355), the requirement that the drug labeling bear “adequate directions for use” (21 U.S.C. § 352(f)(1)), and the need to strictly follow good manufacturing practices, or GMP (see 21 U.S.C. § 351(a)(2)(B)). A number of controls on compounding were included, however, such as the requirement that there be a valid prescription from a licensed practitioner (21 U.S.C. § 353a(a)(1)), that the drug be compounded by a licensed pharmacist (or physician) (21 U.S.C. § 353a(a)(1)), and that the drug be compounded from ingredients that meet certain quality standards (21 U.S.C. § 353a(b)(1)(A)–(B)).
However, § 353a—and with it, all of the provisions and exemptions just mentioned—was held unconstitutional in its entirety in Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001), aff’d 535 U.S. 357 (2002), on the basis of certain restrictions on free speech that were also contained within the statute and which, according to the Ninth Circuit, could not be severed from the remaining provisions because “Congress intended to exempt compounding from the FDCA’s requirements only in return for a prohibition on promotion of specific compounded drugs.” See 535 U.S. at 366. Thereafter, the FDA promulgated a policy by which it would primarily “defer to state authorities regarding less significant violations” but would enforce a number of provisions relating to ingredient standards, unapproved substances, commercial scale production, adulteration, and promotion. The FDA made clear that its enforcement activities “need not be limited to” these or any particular areas, however, thus negating any expectations that Congress’ now-invalidated exemptions might nevertheless provide a safe harbor through the weight of influence, if not law. Since then, the FDA has in fact exercised oversight of compounding pharmacies, as is evident from the handfuls of warning letters that it sends to non-compliant facilities each year. These letters have addressed, for example, promotion that made unsubstantiated efficacy claims, contamination, and the large-scale manufacture of what were essentially copies of FDA-approved drugs.
On October 3, 2012, the FDA’s Division of Professional Drug Promotion issued an untitled letter to Genentech in connection with its cancer drug Tarceva. Tarceva (erlotinib) was approved in 2004 for the treatment of non-small cell lung cancer, and has since been approved, in combination with Gemzar (gemcitabine), for the treatment of pancreatic cancer. Its approval letter reported a tumor response that was 9 times greater with Tarceva than with placebo (0.9% in placebo versus 8.9% in Tarceva), but relatively modest improvements in 1-year survival rates: approximately 8 of 10 patients on placebo did not survive 1 year, while about 7 of 10 patients on Tarceva did not survive (see page 6, line 102 of the approval letter). A 2005 New York Times article was less than enthusiastic about Tarceva’s efficacy, noting that it (along with several other cancer drugs that were new at the time) “help[s] most patients only marginally . . . .” Despite its modest efficacy, Tarceva was reported in the same New York Times article to cost almost $31,000 per year. A number of patents are listed in the FDA’s Orange Book as covering Tarceva until 2020.
The recent untitled letter accused Genentech’s promotional materials of misleadingly indicating that Tarceva in combination with gemcitabine extended overall survival by 3.7 months in comparison with gemcitabine alone, when the actual increase in survival was only about 12 days. The FDA characterized the discrepancy as “drastically overstat[ing] the efficacy of Tarceva.” (The figure of 3.7 months was derived, according to the FDA, “from a retrospective, exploratory subgroup analysis that does not provide substantial evidence to support the efficacy claims cited . . . .”). In addition, the front cover of one of the promotional materials in question contained an image of an hourglass positioned on its side, presented with the claim: “Extending survival for moments that matter.” Although the claim with its associated image may be literally true (“moments” is left undefined), the FDA characterized the image and claim as “drastically overstat[ing] the overall survival benefit for patients” because it “strongly suggests that time is standing still for the cancer patient because of Tarceva therapy.” The FDA noted a number of other instances of misleading overstatement of efficacy or minimization of risk.
The October 3 Tarceva letter brings to 23 the total number of Drug Marketing and Advertising Warning Letters (and untitled letters) listed by the FDA’s Office of Drug Promotion as having been sent this year.


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Recently, the Kentucky General Assembly amended the Unemployment Compensation law in several respects.
KRS 341.415(1) outlines the procedures for recovery and subsequent disposition of improperly paid unemployment compensation benefits. Act of Mar. 21, 2013, 2013 Ky. Laws Ch. 45, § 1(1) (HB 102). Unemployment compensation benefits may be improperly paid because the recipient failed to fulfill a condition, became disqualified, or obtained an award of back pay. Id. KRS 341.415(1) further provides that upon collection of these improper benefit payments, any amount collected shall be credited to the “pooled account” or the account of the “appropriate reimbursing employer.” Id.
During the 2013 Regular Session, the General Assembly added a caveat to the foregoing procedures for disposition of recovered benefit payments. Id. Now, when improper benefit payments are recovered, the account of the appropriate reimbursing employer will not be credited if it is determined that the improper payment occurred as a resulted of that employer’s fault under the amended KRS 341.530(4). Id.; see Id. § 2(4) (stating the circumstances in which an employer is at fault for the improper payment of benefits). Instead, the recovery will be contributed to the pooled account maintained by the Education and Workforce Development Cabinet. Id. § 1(1).
Also, the General Assembly created a new subsection (6) in KRS 341.415. Id. § 1(6). Subsection (6) now penalizes recipients who obtain unemployment compensation benefits “as a result of false statement, misrepresentation, or concealment of material information.” Id. The penalty is calculated as 15% of the amount of the improperly paid benefits, id., and is collected in the same manner as all other improperly paid benefits under KRS 341.415, id. § 1(3), (6). The preexisting subsections of KRS 341.415 were renumbered to accommodate this change.
The General Assembly created two new subsections in KRS 341.530 concerning improperly paid unemployment benefits by reason of the employer’s fault. Act of Mar. 21, 2013, 2013 Ky. Laws Ch. 45, § 2(4)–(5) (HB 102). First, the amended KRS 341.530(4) states that the reserve account of a contributing employer shall not be relieved of any charges relating to an improper benefit payment to a worker if: (1) the improper benefit payment was made because the employer “fail[ed] to respond timely or adequately to a request of the secretary for information relating to the claim for benefits” and (2) the employer “has a pattern of failing to respond timely or adequately to requests.” Id. § 2(4)(a)–(b). A “pattern of failing” means that the employer failed to respond “timely or adequately” at least six times in one year or failed to respond to 2% of such requests in one year, whichever is greater. Id. § 2(4)(b). The new KRS 341.530(4) applies to improper benefit payments that occur after October 21, 2013. Id. § 2(4).
Second, the amended KRS 341.530(5) establishes the notification procedure for determinations made under subsection (4). Id. § 2(5). Notice of the determination will be sent to the last known physical or electronic address of the employer. Id. The determination may be appealed in accordance with the provisions of KRS 341.420(2). Id. In response to the addition of these two new provisions, the legislature renumbered the statute’s preexisting subsections. Id. § 2.
Only minor alterations to KRS 341.550 were made, making the provision compatible with the more extensive amendments to KRS 341.415 and 341.530. Act of Mar. 21, 2013, 2013 Ky. Laws Ch. 45, § 3(2) (HB 102). The legislature inserted cross-references in KRS 341.550(2) to ensure that the pooled account incurred no charges based on improper benefit payments as a result of employers’ fault and to prevent employers’ accounts from being credited with the recovery of such payments. Id.
*Mr. Williamson is a Summer Associate at Wyatt, Tarrant & Combs, LLP.
Categories: Employment Law | Tags: 15% penalty, Employment Law, failure to respond, improper payments, Kentucky General Assembly, KRS 341, recovery of payments, Unemployment Compensation | Permalink.

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Below are key provisions of the Child Care and Development Fund. More detailed information is available throughout this resource guide.
CCDF Plan (ACF-118): By statute, Lead Agencies are required to have in place an ACF-approved CCDF Plan, describing how a Lead Agency will implement the provisions of the Child Care and Development Block Grant Act of 2014 (CCDBG Act) and CCDF regulations to be submitted on a triennial basis.  States are required to submit plan amendments as changes are made in the implementation of the program. In the CCDF Plan, states provide descriptions of the child care program and certify or assure that specific requirements are met as required by the statute. Submission date is July 1st every 3 years (beginning in 2016).
Parental choice: The statute provides for parental choice in allowing parents to enroll their children with providers who have a grant or contract for child care services, or be provided a child care certificate. Lead Agencies are required to offer the choice of a provider who has a grant or contract if such services are available. If provided a certificate, the regulations require parents to be allowed to choose any legally operating child care provider who meets the CCDF health and safety requirements and who is eligible to provide services to families receiving CCDF assistance. A certificate or voucher is defined in the statute as a check or other disbursement that is issued by a state or local government under the statute directly to a parent who may use the certificate or voucher only as payment for child care.
The regulations define child care provider as one who provides child care either in a center, a family home, or in the child's own home.  Care by a sectarian provider, a relative provider, and any other type of legally provided child care are allowable choices.  To receive CCDF Funds, states may not impose health and safety requirements or payment rates that restrict parental choice by excluding any category of care or type of provider; excluding any type of provider within a category of care; limiting access to or choice among categories of care or types of providers; or excluding a significant number of providers in any category or type of care.
Source: CCDBG Act of 2015 658G(a)(2).
By statute, a Lead Agency must certify that it has in effect licensing requirements applicable to child care services provided within the state, and provide a detailed description of such requirements and how they are effectively enforced.
By statute, a Lead Agency must certify that there are requirements in place designed to protect the health and safety of children that are applicable to the providers that serve children supported through CCDF. The requirements must address 10 specified health and safety topics as well as child abuse reporting. With the exception of relative providers, all providers of care to children supported through CCDF must meet the basic health and safety standards—whether through licensure or regulation or through requirements designed by the Lead Agency that apply to unregulated providers serving families receiving CCDF.
 CCDBG Act of 2014 658E; Child Care and Development Fund, 45 C.F.R. § 98.16 (2016).
 CCDBG Act of 2014 658P(3); Child Care and Development Fund, 45 C.F.R. § 98.20 (2016).
 CCDBG Act of 2014 658P(6); Child Care and Development Fund, 45 C.F.R. § 98.2 (2016).
 CCDBG Act of 2014 658E(c)(3)(B)(i); Child Care and Development Fund, 45 C.F.R. § 98.46 (2016).
 Lead Agencies may limit the use of in-home care [Child Care and Development Fund, 45 C.F.R. § 98.30(f)(2) (2016)].
 CCDBG Act of 2014 658E(c)(2)(A); Child Care and Development Fund, 45 C.F.R. § 98.30 (2016).
 Child Care and Development Fund, 45 C.F.R. § 98.33 (2016).
 Child Care and Development Fund, 45 C.F.R. § 98.45(l) (2016).
 Child Care and Development Fund, 45 C.F.R. § 98.45 (2016).
 Child Care and Development Fund, 45 C.F.R. § 98.45(k) (2016).
 Child Care and Development Fund, 45 C.F.R. § 98.54 (2016).
 CCDBG Act of 2014 658E(c)(3)(E); Child Care and Development Fund, 45 C.F.R. § 98.50(f) (2016).
 Child Care and Development Fund, 45 C.F.R. § 98.50(e) (2016).
 Child Care and Development Fund, 45 C.F.R. § 98.50(b) (2016).
 CCDBG Act of 2014 658G(b); Child Care and Development Fund, 45 C.F.R. § 98.41 (2016).
 CCDBG Act of 2014 658E(c)(2)(E); Child Care and Development Fund, 45 C.F.R. § 98.40 (2016).
 CCDBG Act of 2014 658E(c)(2)(I-L); Child Care and Development Fund, 45 C.F.R. § 98.41 (2016).
 CCDBG Act of 2014 658H.


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Flanging is a modulation effect based on swept comb filtering. It was first created in the 1940s* by using two tape recorders. The tape recorders played the identical recording but one was slightly altered in speed by slowing down one reel. Therefore the engineer (e.g. Phil Spector) put one finger on the flange (or rim) of the reel – thus the name flanging. In the 1970s dedicated flanging machines came up but were limited to studios due to their size. Artist who published songs at that time using flanging are e.g. Queen, David Bowie, The Rolling Stones, ELO, The Eagles. The first Flanger using anlogue delay and no tape probably was the Eventide FL201 in 1975.
Electro-Harmonix recognized the need of guitarists to be able to produce flanging live on stage and David Cockerell developed a such device using an analogue delay. Being a genius synthesizer inventor helped him a lot as the major component which had to be developed was the LFO, also a major component in synthesizers at that time.
Similar to the first tape flanging machines the Electric Mistress also uses two identical signals, one being time delayed. But let’s just travel with the signal through the device. I use the Electric Mistress V2 for explanation (see schematic below).
The input signal passes from the guitar by the input socket to a buffer. A buffer is an operational amplifier with gain of 1. It’s easy to recognize in schematics as op-amp with its output directly connected to the inverting input. Gain of 1 means the volume of the output signal is identical to the volume of the input signal. The sense of the buffer is not to amplify the signal but to do impedance transformation. In simple terms spoken its job is to decouple the effects pedal from the guitar and to avoid that anything happening in the effects pedal may influence the guitar’s sound. Later versions don’t use a buffer with gain 1 but a slight amplification to avoid the volume drop the vintage versions have.
After the buffer the signal passes through a high pass filter to reduce the low frequencies and avoid aliasing effects by the BBD (don’t worry, they will be restored later) and enter the gain stage. The gain stage is used to boost the volume of the signal to compensate the losses of splitting and filtering and to improve the signal to noise ratio.
Leaving the gain stage the signal is spitted into the dry signal and the signal to be delayed by the BBD (see own section). The output of the BBD is connected to a high pass filter and a coupling capacitor to keep the bias off the output.
Now we reach the crossroads where a part of the signal passes the feedback trimmer and the COLOR pot and is feed back to the input of the gain stage. The function of the feedback is to intensify the effect by increasing the comb filter effect.
Finally the dry signal and the delayed signal are mixed together and filtered to regain a linear frequency response in the audible range. The resulting signal leaves the device by the On/Bypass footswitch and the output socket.
The following sketch illustrates how comb filtering is achieved by mixing a dry and delayed signal. The physical principle is interference. Dashed red is the dry signal, dotted green is the delayed signal and blue is the resulting sum. Every delay time affects a different frequency. That’s why different delay times will create different ‘sounds’.
Using a constant delay time for the delayed signal already generates an effect (that’s what you hear when you run the Mistress in Filter Matrix mode), but the fun starts when the delay time is swept. The swept delay time is commanded by the LFO which can be set by the RATE and RANGE pot. A detailed description of the LFO follows below.
To operate the BBD it needs a clock signal. The clock also determines the delay time. To convert the LFO output voltage to a clock with according high frequencies a VCO is used (see below).
Finally we have the voltage regulation. Its job is simply to regulate the 18 V supply to 12 V. A regulation is needed as the supply voltage will vary when using batteries and also DC adapter may vary. To achieve the specified delay times the LFO and VCO need an exact voltage, in our case 12.0 V (but it will also work from 12.0 to 13.5 V with slightly shifted delay times).
The voltage regulation is a typical standard op-amp regulator. We have a reference voltage from a 6.8 V Zener diode, an op-amp and a transistor. The voltage divider connected to pin 3 of the op-amp defines the voltage. This voltage is also used to feed the bias trimpod which is also used as a voltage divider. The bias voltage is needed because our signal is alternating currency (AC) and we only have positive supply voltage. The negative half wave of the signal could not be processed by the op-amps and the BBD. The bias voltage sets the origin of the AC signal to bias voltage. E.g. a +- 1 V AC voltage set to 6 V bias now ranges from 5 V to 7 V.
The sweep of the Electric Mistress’ delay time is generated by a LFO (low frequency oscillator). How long one sweep cyle takes is set by the RATE pot. The rate of the maximum output voltage to the minimum output voltage is set by the RANGE pot.The voltage of the LFO is equal to the delay time (low voltage = short delay | high voltage = long delay). See measurements of the Mistresses LFO. The maximum voltage range out of the LFO is different than the voltage commanded in Filter Matrix mode. Especially the Deluxe Electric Mistress V4 and V5 Reissue has a Filter Matrix range of 1.4 V to 8.5 V whereas the LFO ranges only from 1.0 V to 5.1 V.
The heart of all Mistresses LFOs and VCOs are comparators. The most important thing with comparators is that you keep the following in mind. If the voltage at the noninverting input is greater than the voltage at the inverting input its output is high (supply voltage), if the voltage at the noninverting input is equal or lower than the voltage at the inverting input its output is low (0 V).
The LFO is rather complicated. It consists of two comparators and a Flip-Flop. The Flip-Flop works like a switch commanding if the LFO voltage (VLFO) is de- or increasing. The Flip-Flop inputs CLOCK and DATA are attached to ground so we use only SET and RESET. The outputs are Q and inverse Q.
The RESET input pin 4 of the 4013 is equal to 0.6 * VLFO . If the RESET voltage is lower than 6 V it is considered low, if it is higher than 6 V it is considered high. The SET input is fed by pin 13 of the LM339. V+ (pin 11 LM339) is set to a constant voltage of 0.4 V. VLFO is attached to V- (pin 10). If VLFO is smaller than 0.4 SET is set to high by pin 13 of the LM339. If VLFO is greater than 0.4 V SET is set to low.
At the beginning SET is high and RESET is low. Q is high and Qinv is low which will give the charging command. VLFO rises. If VLFO is greater than 0.4 V SET is set low but the Flip-Flop keeps its state. VLFO keeps rising. If RESET reaches 6 V the Flip-Flop toggles and the discharging command is given. VLFO decreases. RESET falls to low, but the Flip-Flop keeps its state. VLFO decreases. If VLFO drops below 0.4 V SET is set high and the cycle starts from beginning.
In the above it says Q and Qinv command charge and discharge, but how? Q and Qinv are connected via two different resistors which form a voltage divider. If Q is low and Qinv is high, the voltage to the RATE pot is 9 V. If Q is high and Qinf is low, the voltage to the RATE pot is 3 V.
V+ (pin 5 LM399) is set to constant 6 V. If Q is high and V- (pin 4 LM399) is 9 V the output pin 2 is high. The 2.2 uF capacitor will be charged by the 4.7 k resistor. If Q is low and V- is 3 V the output pin 2 is low. The 2.2 uF capacitor will be discharged by the comparator.
To explain how the RATE command works we need to concentrate on the 2.2 uF capacitor. One side is attached to VLFO the other side is attached the Q/Qinv charge/discharge command voltage. If VLFO rises, the VLFO charging voltage is the positive potential and Qinv is the negative potential. The smaller the RATE resistor is, the higher the charging current for the transistor is and the faster VLFO rises. If VLFO falls, pin 2 LM399 is the negative potential and Qinv is the positive potential. The smaller the RATE resistor is, the higher the discharging current for the transistor is and the faster VLFO falls.
The VCO (voltage controlled oscillator) is used to generate a signal with a certain frequency dependent on the input voltage. See measurements of the Mistresses VCO.
The LFO voltage sets the reference voltage at pin 7 of the LM399. Pin 8 is set to a constant small voltage. The BC177 serves as constant current source. It gradually charges the 470p capacitor and in consequence the voltage at pin 6 gradually rises. The output pin 1 is high which sets pin 9 via the 1N914 high, too.
At the point where the voltage at pin 6 is equal to the LFO voltage the output at pin 1 toggles to low. Pin 9 drops to low which means pin 14 toggles to low. The 470 capacitor is discharged over pin 14 which means pin 6 drops below pin 7 and pin 1 toggles back to high. Pin 9 is set to high which will toggle pin 14 to high. The 470p capacitor gets charged again and the cycle starts again.
The higher the LFO voltage is, the longer it takes to charge the capacitor until the comparator toggles. In consequence the higher the LFO voltage is, the lower the VCO frequency is.
As the VCO doesn’t generate a strict rectangular signal with equal high and low periods a D-FlipFlop (4013) is used to create a square signal and an inverted square signal with half of the VCO frequency. The Flip Flop is toggeling its output state every time the input at pin 11 is changing from low to high.

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