E-cigarettes. Generic drugs. A guide to the FDA in 2016
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WASHINGTON — Election years tend to turn federal agencies into political footballs, and already candidates are pushing the Food and Drug Administration to lower drug costs — a matter on which the agency has only indirect influence.

The FDA does have influence over a vast array of other issues, however, and the decisions it makes in 2016 will have significant implications for the lives of many Americans.

While it doesn’t typically get the same attention as, say, the Defense Department or the Justice Department, the FDA has jurisdiction over some 20 to 25 cents out of every consumer dollar. In other words, the actions it takes matter, big time, and the agency has a great deal other than drug prices on its agenda for 2016. The FDA is also set to get new leadership, with the Senate expected to confirm Dr. Robert Califf as its new commissioner.

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Here’s a look at some of the biggest issues on the agency’s agenda for the new year.

Crackdown on e-cigarettes

It’s been a long haul, but there are big changes on the way for e-cigarettes.

The FDA’s proposal to oversee electronic cigarettes will likely be finalized in 2016. The so-called “deeming rule” would extend the agency’s authority to regulate e-cigarettes, and likely require pre-market review of the devices — a process that is used to determine whether potentially risky products are safe. The FDA is also expected to ban e-cigarette sales to minors under age 18 and require labels stating that they contain nicotine.

E-cigarette makers say that they help smokers quit. There is evidence from a small numbers of studies that this is true, although researchers say more studies are needed. But many public health advocates consider e-cigarettes a gateway to smoking tobacco cigarettes. There is also increasing evidence that some of the flavorings may be hazardous in themselves.

The FDA is working on a separate plan to require broader warnings about nicotine hazards — especially from accidental exposure to children and infants. The agency might also require child-proof packages for e-liquids, which are liquid nicotine combined with colorings and flavorings.

Rethinking how drugs can be marketed

Pharmaceutical ads
STAT

Until last summer, drug and device makers needed to prove that their products were safe and effective to treat a specific disease before they could be marketed for that purpose. Off-label prescribing has long been common, but companies are typically careful not to encourage these unapproved uses in writing.

A landmark decision in August started eroding that restriction. A US District Court judge ruled that fish oil company Amarin Pharma Inc. had a First Amendment right to give doctors truthful, scientific information on unapproved uses for its drug Vascepa, which is taken to reduce triglycerides. The ruling caused an uproar at the FDA and among public health advocates, who feared an onslaught of unproven claims would confuse consumers. But drug and device companies hope it will usher in looser standards for marketing and advertising.

The case caused the FDA to begin revamping its rules. In December, 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.

As the FDA revises its rules, it’s also trying to work out a settlement with Amarin, which has retained First Amendment lawyer Floyd Abrams.

The generics backlog

Pills Generic
APStock

At a time when skyrocketing drug prices have become a serious drain on consumers’ finances, lawmakers are looking to generic drugs as an alternative. Far cheaper than brand-name drugs, generic, or copycat, drugs are more in demand than ever. They also account for 88 percent of all prescriptions in the United States, but only 28 percent of the cost, according to the Generic Pharmaceutical Association.

But more than 4,300 applications are now awaiting approval at the FDA, and while the agency has sped up its review process, manufacturers argue that it still isn’t moving fast enough. For its part, the FDA says that many applications are deficient and that generic drug companies submit reports lacking critical information solely to win a space in the queue, and plan to fix them later.

Over the next year, the agency will try to whittle down the number of pending applications. But the FDA also is expected to finalize a rule that would permit generic companies to update their labels with safety information without prior FDA approval. The rule comes with a catch that has made much of the industry oppose it: increased liability in the case of safety problems.

The money pot

J. Scott Applewhite/AP
J. Scott Applewhite/AP

The FDA regulates drug makers and device manufacturers, but it also relies on them to operate.

Congress has authorized various measures that are important and that must be reauthorized every five years. Like so much legislation in Washington, they also come with terrible acronyms. The earliest to pass, the Prescription Drug User Fee Act (PDUFA), authorizes the FDA to collect money from companies that produce certain human drug and biological products. Subsequent measures have forced manufacturers to pay fees to offset the costs of regulating generic drugs (GDUFA), medical devices (MDUFA), and biosimilar biological products (BsUFA).

As part of the reauthorizations, the FDA also agrees to certain performance goals, which are negotiated with lawmakers, industry lobbyists, and administration officials well ahead of the congressional vote.

Negotiations on the reauthorization of the measures started with a public meeting at the FDA in July and are expected to conclude next fall. 

The FDA’s goals for reauthorization of user fee acts include: increased patient participation in drug development and review; expansion of FDA’s Sentinel program to strengthen oversight of post-marketing safety; and the ability to use funds to hire and retain top talent.

The industry is also pushing for the FDA to consider “real-world” evidence outside of clinical trials. Some FDA officials have supported this concept, but others believe it might erode safety.

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