FDA’s Agenda for 2016: Biggest Issues on Agency’s Calendar for the New Year

PS 4 Indest-2009-3By: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Food and Drug Administration (FDA) has great influence on a vast array of issues impacting the medical industry in the U.S. The decisions it makes in 2016 will have a significant impact for health care providers and on the lives of many Americans. Here is a look at the top issues on the agency’s agenda in 2016.

Reigning in E-Cigarettes.

The use and health of electronic cigarettes (e-cigarettes) have been hot topics between Americans for years and big changes are on the way in 2016. The FDA’s proposal for 2016 will grant the agency permission to oversee e-cigarettes. The proposal, called the “deeming rule,” will give the agency authority to regulate and require pre-market reviews for e-cigarettes. This process will be used to determine which products are safe and which could be potentially dangerous to consumers.

In addition, the FDA seeks to ban e-cigarette sales to minors and require all packages to have a warning label stating that the product contains nicotine. To read more on the FDA’s regulations on e-cigarettes and other tobacco products, click here.

Regulating Drug Marketing and Advertising.

Until recently, drug manufacturers were required to prove that their products were safe and effective before they could be marketed or advertised to treat a specific ailment. Off-label prescribing is nothing new in this industry, but companies are usually careful not to encourage unapproved uses.

Recently, a significant case involving Amarin Pharma Inc., and the availability of information for unapproved uses, caused the FDA to revamp its rules. In this case, Amarin Pharma Inc. won an injunction against the FDA’s ban on off-label marketing. To read our previous blog on this case, click here.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, wrote that the agency’s front-burner priorities for 2016 included reevaluating regulations for drug advertising and promotion. To read further on off-label marketing, click here.

The Backlog of Generic Drugs.

Escalating drug prices have become a serious drain on consumers’ wallets and lawmakers are looking to generic drugs as an alternative. Currently, about 4,300 applications for generic drugs are waiting approval or rejection by the FDA. The FDA blames drug manufacturers for careless and incomplete applications that slow the process, but the availability of generic drugs to the consumer is the bottom line.

Sometimes referred to as copycat drugs, generic brand drugs are between 30 and 80 percent cheaper than brand-name drugs. Generic drugs account for 88 percent of all prescriptions in the United States, but only 28 percent of the cost, according to the Generic Pharmaceutical Association.

In the year 2016, the FDA looks to finalize a rule that would permit generic drug companies to update labels with important safety information without prior FDA approval. This rule however, comes with a catch: increased liability in the case of safety problems. To read more on this problem from the American Pharmacists Association, click here.

Fees for Services.

While the FDA is charged with regulating drug manufacturers, it also relies on these companies for its continued operation. It charges fee to companies that manufacture generic drugs in order to offset the costs of regulating them and fees for other aspects of its operations.

Congress approved several important measures for 2016, which require reauthorization every five years. First, the Prescription Drug User Fee Act (PDUFA), authorizes the FDA to collect money from companies that produce certain human drug products. These measures have been enacted to force manufacturers to pay fees to offset the costs of regulating generic drugs.

As part of these new measures, the FDA has agreed to certain performance goals. These goals include: increased patient participation in drug development and review, expansion of the FDA’s Sentinel program to strengthen oversight of post-marketing safety, and the ability to use funds to hire and retain top talent.

New Year, New Decisions.

Not only does the FDA face several significant decisions in 2016 that greatly impact the lives of many Americans, but the industry is pushing for “real-world” evidence outside of clinical trials. The FDA has jurisdiction over some 20 to 25 cents out of every consumer dollar. In short, the decisions the FDA makes matter, big time.


What are your thoughts on the FDA’s biggest issues in 2016? Do you agree with the tactics the FDA is using to tackle these issues? Is there an important issue that you think should be added?

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Kaplan, Sheila. “E-cigarettes. Generic Drugs. A guide to the FDA in 2016.” STAT. (January 4, 2016). Web.

U.S. Food and Drug Administration. “Electronic Cigarettes (e-Cigarettes).” Public Health Focus. (January 10, 2016). Web.

Kaplan. Sheila. “Backlog of unapproved generic drugs helps boost drug prices.” STAT. (December 29, 2015). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.


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