Lawmakers Focus on Rx Drug Prices, Competition


I attended two hearings this week on Capitol Hill that focused on recent prescription drug price increases and the need for more competition.

At a Sept. 21 Senate panel hearing on the Food and Drug Administration’s role in the generic drug marketplace, senators pushed the leader of the FDA’s drug office for answers about why drug prices are increasing and they there isn’t more competition for Mylan’s EpiPen allergy injection. The hearing of the Senate Appropriations subcommittee on agriculture, rural development, the FDA and related agencies came on the same day as a House hearing on Mylan’s price hikes for its EpiPen.

The FDA doesn't regulate the cost of drugs, but the cost of drugs to consumers—and the role of generics in reducing costs—dominated the Senate hearing on the FDA's generic drug approvals.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told the Senate panel that the FDA is aware of the recent price increase of Mylan's EpiPen. She said the FDA has approved four brand epinephrine auto-injector products to treat anaphylaxis. Two of those are currently on the market, one of which is the EpiPen. Woodcock was the panel's sole witness.

The House also is looking into drug prices. At a Sept. 22 hearing, a House panel examined the costs of medicines that treat opioid addiction and overdose.

Rep. Tom Marino (R-Pa.) said during the hearing that the prices of both brand and generic naloxone and buprenorphine products are reportedly increasing dramatically, which is affecting patient access. Naloxone is used to reverse the effects of opioid overdoses and buprenorphine is used to treat addiction. The House Judiciary Regulatory Reform, Commercial and Antitrust Law Subcommittee held the hearing to examine the addiction medicine market.

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