Pharma Regulation in 2020 – Webinar Recording/Transcript

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Pharma Regulation in 2020: FDA Priorities in the Upcoming Election Year

Want to attend the live webinar on Dec. 10?  Click here to register.

What pharma regulatory issue will have the greatest impact on you in 2020?

It’s no secret that one of the biggest hot-button issue today and in the upcoming election year will be high drug costs. The drive to change how drugs are financed and regulated will be front-page news in 2020. FDA will play a role in the drug pricing debate, especially with regard to new drug approvals and the regulation of generic drugs and biosimilars.

In addition, FDA will have a new commissioner in 2020.  He will set priorities for the drug and biologics centers.  He will need to address issues such as drug shortages, manufacturing challenges and drug importation policies.

For your company to remain competitive, you must anticipate how new guidelines, regulations and policies will affect your company. Prepare today by planning and prioritizing your business interests to the upcoming changes.

This webinar is your crystal ball into how the key regulatory and related issues affecting pharmaceutical quality, regulatory and compliance specialists will be addressed by the FDA in 2020.

Presentation Takeaways:

  • The key issues facing the regulation of drugs in 2020, including the status of drug pricing legislation and the regulation of advances in new drug therapies
  • The changes we are likely to see, including the evaluation of gene therapies and continued focus on orphan drugs
  • FDA’s likely priorities next year, including incentivizing generic drug approvals and renewed focus on opioids
  • How these changes affect aspects of drug regulation and oversight, including drug applications, FDA reviews, prescribing and drug marketing
  • The strategies companies can adopt in anticipation of these changes

Be among the first to gain the information you need to plan for the upcoming industry changes.

  • Regulatory Officials
  • Quality Officials
  • Compliance Officials
  • Legal and Marketing Officials at pharmaceutical companies, and the agencies and consultants who work for them

Meet Your Presenters
Wayne L. Pines is the President, Health Care, of APCO Worldwide. He provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing challenges involving FDA-regulated products. Mr. Pines served in senior positions at the FDA for 10 years, including as FDA’s chief of consumer education and information, chief of press relations and associate commissioner for public affairs. Mr. Pines was the chief media spokesman for the FDA for seven years and was the founding editor of the FDA’s consumer magazine. He is the incoming president of the Alliance for a Stronger FDA and has written or edited 14 books about FDA.

Kevin Madagan is a health care and FDA regulatory attorney and member of the Reed Smith Life Sciences Health Industry Group. He advises clients across the health care spectrum about health care and FDA issues related to the manufacturing, distribution, and sale of drugs (Rx, OTC, homeopathic), biologics, devices (Rx and OTC), and dietary supplements. His clients include suppliers, manufacturers; repackagers; wholesale and private label distributors (PLD); third-party logistics providers (3PLs); carriers; pharmacies (503A, 503B, nuclear and radiopharmacy operations); and health care providers.

Dr. John F. Kamp has been involved with FDA policies for several decades. He deals with policies involving drug development and approvals, with an emphasis on the promotion and marketing of medical products. Dr. Kamp is Washington Counsel for the Coalition for Healthcare Communication, a drug marketing group with offices in New York City and Washington, DC. Kamp is well-known as an advocate for First Amendment rights of individuals and corporations, as well as for his understanding of communication and drug/device issues at the FDA. His professional experience includes 10 years with the Washington office of the American Association of Advertising Agencies and nearly a decade in public policy positions at the Federal Communications Commission. Before moving to Washington, Dr. Kamp taught journalism at the University of Iowa and at Tulsa University. Dr. Kamp is a frequent speaker at drug industry meetings on ethical, legal, and political issues surrounding drug marketing and drug development, and is recognized as an authority on these issues by the print and broadcast press. He serves on the editorial boards of the Rx Compliance Report, Medical Marketing and Media, and the FDA Advertising and Promotion Manual. Dr. Kamp is co-author (with Wayne Pines) of 3 books on compliance with FDA policy published by FDA News, including DTC Advertising and Promotion: The Changing Environment, published in January 2006.

Tish Eggleston Pahl is a principal at OFW Law. She is regulatory counsel to drug, cosmetic, dietary supplement, and food clients with concerns before the Food and Drug Administration, the Federal Trade Commission, and other federal agencies. Her work has encompassed representation of companies making and marketing human and animal prescription and over-the-counter (OTC) drugs, dietary supplements, and cosmetics. She has particular expertise in the areas of medical product supply chain integrity, health care communications, health care policy and legislation, regulatory compliance, open payments requirements, advertising, and labeling of FDA-regulated products, and advocacy of commercial First Amendment speech rights under the United States Constitution. Further, she advises trade association clients on a range of antitrust and trade regulation issues. Tish closely monitors and analyzes the rapidly changing legislative, regulatory, and legal environment for a variety of health care clients.