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Schrader bill would speed up federal drug review

Plan introduced months before controversy erupts over soaring price of allergy drug.

Five months before the controversy erupted nationally last week, U.S. Rep. Kurt Schrader sponsored legislation to speed up federal approval of generic drugs, such as an injector that delivers a medicine to counteract severe allergic reactions.

Schrader, a Democrat who represents Oregon’s 5th District, discussed his bill Wednesday (Aug. 24) as he responded to a question about the soaring price of injectors known as EpiPens.

The bill would apply to drug companies, he said, “when they come into a market where there is only one drug or one manufacturer that can hold us hostage with whatever price it wants to charge, and allow these drugs to come to market much quicker.”

Schrader spoke during a luncheon of the Oregon City Rotary Club.

Schrader introduced the bill (HR 4784) in March, when it was assigned to the health subcommittee of the House Energy and Commerce Committee. Schrader sits on both panels. The Democrat from Canby has a Republican cosponsor, Rep. Gus Bilirakis of Florida.

The bill has not advanced, but Schrader said he is optimistic that the public attention will prod its movement.

The issue gained national momentum this past week when a protest spread by social media questioned the soaring price of EpiPens, which have surged by more than 500 percent in recent years. After coverage by news media focused on Mylan, the pharmaceutical company that makes the devices, its chief executive — also the daughter of U.S. Sen. Joe Manchin of West Virginia — pledged to expand coupon and patient assistance programs to patients facing higher out-of-pocket costs. She was silent about whether the price itself would be reduced.

A twin pack of such devices is being pegged at $600, up from around $90 almost a decade ago. The company subsequently announced that it will offer a generic version at about half the cost.

The injector delivers a dose of epinephrine, which counteracts a severe allergic reaction that can be fatal.

Although the Rotary Club questioner specified EpiPens, Schrader said his bill applies to a range of medicines.

The legislation would require the Food and Drug Administration to act on generic-drug applications within six months of submission when there is no equivalent generic drug on the market, or when there is a drug shortage.

The bill also encourages generic-drug development by designating priority review for future generic-drug applications when a company successfully markets a new generic competitor.

“It (FDA approval) is a long process, and if FDA has all these other products in the queue, this bill allows them to jump to the top of the queue because it’s so important to the American consumer,” Schrader said.

“I like to think ours gets to the heart of the issue.”

The bill also seeks to study and address questions as to whether current Risk Evaluation and Mitigation Strategies (REMS) are being used to limit entry of generic drugs into the market.

Schrader is seeking a fifth term in the 5th District, which takes in most of Clackamas County and a sliver of Multnomah County.

In a statement he issued back when he introduced the bill in March, Schrader said:

“We’ve seen some outrageous cases where greedy Wall Street speculators have caused drug prices to skyrocket 5,000 percent overnight. Some of our most vulnerable constituents depend on access to life-saving pharmaceuticals. We know many of these patients’ costs could be lowered if generic competitors were available.”

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