United States: FDA And Pharmacy Weekly Digest - April 9

Sharpless Begins as FDA Acting Commissioner – On April 5, Norman E. "Ned" Sharpless, M.D., became the acting commissioner of the FDA. Previously he was the director of the National Cancer Institute.

SEC Chairman Release Statement on Commissioner Gottlieb's Departure – The chairman of the U.S. Securities and Exchange Commission released a public statement thanking Commissioner Gottlieb for his service. He stated, "In carrying out my responsibilities as Chairman of the SEC, I have looked internally and externally for benchmarks – ways to measure the effectiveness of our efforts and identify opportunities for improvement. For the past two years, I have often looked to Dr. Gottlieb as a shining standard for agency leadership. Dr. Gottlieb, thank you for your service, and for the example you have set."

Food/Dietary Supplements

April Is Winning on Reducing Food Waste Month – In partnership with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency, the FDA announced the beginning of Winning on Reducing Food Waste Month. The Commissioner called for "greater collaboration with public, private, and nonprofit partners, as well as state and local officials, to educate and engage consumers and stakeholders throughout the supply chain on the need to reduce food loss and waste."


FDA Warns Homeopathic Product Producers – The FDA warned four producers of homeopathic products about "significant violations of current good manufacturing practice regulations," including lack of "quality oversight while manufacturing homeopathic drug products containing ingredients with potentially toxic effects for consumers, including snake venom."

FDA Focuses on Insulin Pricing – The FDA reiterated its continued focus on the need for competition in the insulin market. One of the FDA's plans is to change the approval pathway for insulin from a drug approval pathway to a biologics approval pathway, which the FDA believes "will open up these products to biosimilar competition." FDA Commissioner Gottlieb stated that the FDA is "already seeing robust activity among sponsors seeking to bring forward biosimilar copies of insulin." The FDA will also hold a public hearing on May 13, 2019, "to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products."

FDA Evaluates Regulatory Pathways for Cannabis Products – The FDA announced its continued efforts to evaluate the possibility of regulatory pathways for products containing cannabis and those derived from cannabis. The FDA plans to hold a public hearing on May 31, 2019, to "give stakeholders an opportunity to provide the FDA with additional input relevant to the agency's regulatory strategy related to existing products, as well as the lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient." The FDA has also formed a working group to focus on the topic and issued "multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations."

FDA Expresses Concern About Certain Stem Cell Products – The FDA issued a press release reiterating the importance of stem cell products and research; however, it also addressed bad actors, stating that "some actors are leveraging the widespread belief in the eventual promise of these products, flouting the statutes and our regulations, and deceiving patients by illegally manufacturing or selling purported therapies, and falsely promoting their benefits. This ultimately puts at risk the very patients they claim to want to help."

FDA Warns Genomics Lab for Marketing Unreviewed Genetic Test – The FDA announced the issuance of a warning letter to a genomic laboratory for marketing genetic tests that "have not been reviewed by the FDA for safety and effectiveness." The release states, "The tests claim to predict patients' responses to specific medications based on genetic variants. Selecting or changing drug treatment in response to the test results could lead to potentially serious health consequences for patients. The FDA is unaware of any data establishing that Inova's tests can help patients or health care providers make appropriate treatment decisions for the listed drugs."

FDA Issues REMS Guidance – The FDA released a guidance titled "REMS: FDA's Application of Statutory Factors in Determining When a REMS Is Necessary." The guidance is meant "to clarify how the Food and Drug Administration ... applies the factors set forth in section 505-1 of the Federal Food, Drug, and Cosmetic Act ... (21 U.S.C. 355-1) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks."

Medical Devices

FDA Addressed Medical Devices Based on Artificial Intelligence (AI) – The FDA is considering a new regulatory framework for AI-based medical devices. FDA released a discussion paper "to help developers bring artificial intelligence devices to market."

FDA Seeks to Bolster Access to Animal Product Adverse Event Reports – The FDA announced that it will make available adverse event reports related to medical devices used in animals and animal drug products going back 30 years.


FDA Announces Workshop to Support Youth Tobacco Cessation – The FDA will hold a public scientific workshop on May 15, 2019, to "discuss scientific understanding and treatment options for youth tobacco addiction and cessation, with a focus on e-cigarette cessation."

FDA Investigates Seizures Reported After E-Cig Use – The FDA notified the public of a potential safety issue related to e-cigarette use. It stated, "We have reports indicating that some people who use e-cigarettes, especially youth and young adults, are experiencing seizures following their use." The FDA also stated, "We want to be clear that we don't yet know if there's a direct relationship between the use of e-cigarettes and a risk of seizure. We can't yet say for certain that e-cigarettes are causing these seizures."


Congress Questions Commissioner Gottlieb on Compounding – During the House Appropriations Committee Hearing on April 3, Rep. Cuellar asked, "How is the FDA taking small pharmacists' issues with regulations regarding distribution and dispensing of medications into consideration?" Commissioner Gottlieb responded, "What we want to do is make it easier and less expensive for the 503A pharmacies to become 503B pharmacies, outsourcing facilities, and what we ‒ what we believe is by developing a center that can work more directly with pharmacies, help them ‒ help train them on how to meet GMP requirements, provide a higher level of touch, train them on how to be inspected."

Commissioner Gottlieb Comments on Opioid Summit – The FDA held its second Online Opioid Summit. Commissioner Gottlieb's comments focused on illicit internet trafficking of opioids. He stated, "Cutting off this illicit internet traffic is critical. And we'll continue to pursue all available means of enforcement to stop these online drug dealers." He indicated that the FDA and U.S. Customs and Border Protection will be "working to maximize each agency's inspection and detection capabilities to protect Americans from illegal and harmful products entering the U.S. through the nation's International Mail Facilities and Ports of Entry."

FDA Warns Internet Providers of Opioid Medications – The FDA issued warning letters to two "websites that illegally market potentially dangerous, unapproved and misbranded opioid medications, including tramadol."

FDA Seeks to Improve the Quality of Compounded Drugs – Commissioner Gottlieb and Deputy Commissioner Abram issued a statement about the FDA's commitment to quality compounded drug products. They stated that the FDA plans to use appropriated funds to set up the Center of Excellence on Compounding for Outsourcing Facilities, which will include "trainings on current good manufacturing practice requirements for outsourcing facilities. The goal will be to bolster the quality of compounded drugs produced by outsourcing facilities." They also stated that the FDA plans to finalize the compounding memorandum of understanding in 2019. In addition, on May 21, 2019, the FDA will hold a public meeting titled "Drugs Compounded for Office Stock by Outsourcing Facilities." This meeting is intended to give "health care professionals, outsourcing facilities, and other stakeholders an opportunity to discuss access to office stock from outsourcing facilities considering the policies proposed in the revised draft guidance Current Good Manufacturing Practice Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act."

VA Passes Law Adding Pharmacy Protections – The Virginia legislature recently passed HB2561, which provides additional protections to pharmacies interacting with pharmacy benefit managers. The law requires that PBM contracts contain certain terms relating to pharmacy audits, including a 14-day notice period.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions