Senate pushes FDA to clear 3,500+ generic prescription drugs in backlog

FDA's Dr. Janet Woodcock talks to staff after Senate hearing. (Credit: Chance Seales)

WASHINGTON (MEDIA GENERAL) – More than 3,500 new generic prescription drugs currently sit on shelves, fully developed, awaiting FDA approval. Now, U.S. senators are applying pressure for the agency to speed up its work.

The Food and Drug Administration’s approval process “does not seem to be living up to Congress’ or the people’s expectations,” declared Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health Committee at a Thursday hearing.

Generic drugs make up 88% of all prescriptions in the United States and have saved consumers an estimated $1.7 trillion in the past 30 years.

But with several thousand generic options in limbo, despite increased funding, senators are showing impatience.

It’s “staggering to think of the savings that were lost” due to these delays, lamented Sen. Orrin Hatch (R-Utah).

In 2012, Congress passed the Generic Drug User Fee Amendments (GDUFA), allowing the FDA to collect fees from pharmaceutical companies seeking approval in order to beef up staff and expedite inspections.

Sen. Alexander reminded colleagues that the current state of affairs not only costs individual consumers extra cash, but charges taxpayers billions of dollars in medications for Medicare and Medicaid recipients.

The FDA is tasked with expediting the generic drug approval process, optimally within 180 days, according to previous legislation written by Hatch. Thanks to 2012’s GDUFA, that goal changed to 15 months.

Currently, FDA approval averages 48 months.

Hatch asked Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, if her agency’s backlog keeps potentially life-saving drugs off the market and reduces competition. Woodcock answered with a simple “Yes.”

When Hatch pressed for assurance that Woodcock’s staff will clear the 3,500+ backlog before Congress passes GDUFA (often pronounced guh-DEW-fuh) again in 2017, Woodcock replied, “Absolutely.”

Woodcock used the hearing to tout the FDA’s overall progress as a “success story,” noting that “over 90% of [existing] applications have received some review” and that new applications face a shortened wait period.

The FDA is shooting for a 10-month approval process, start to finish, beginning in September 2016

Seemingly unimpressed with the agency’s track record thus far, Sen. Alexander noted, “You’ve collected a billion dollars [in fees] and hired 1,000 new people” yet can only point to a four-year waiting period.

Woodcock maintained a sunny outlook, telling reporters her agency has invested in modernizing its infrastructure and is “just going to crank the next two years” to meet critical deadlines.

Democrats on the HELP Committee acknowledged the importance of approving new generics, but largely focused on the dangers of soaring drug prices.

“Let’s not kid ourselves … real change will require us to face the fact that the market for prescription drugs is not working,” asserted Sen. Elizabeth Warren (D-Mass.).

Sen. Chris Murphy (D-Conn.) echoed Warren’s sentiments, acknowledging that the FDA does not set drug prices, but pushed for renewed efforts to stop a surge in prescription costs.

The committee’s top Democrat, Sen. Patty Murray (D-Wash.), said, “Sadly, the status quo is working all too well for some bad actors at the top.” Murray invoked Martin Shkreli by name, pointing to his actions as an example of bad behavior exhibited by top executives in the drug industry.

Senators repeatedly characterized the proliferation of generic drugs as a “success story” — a trend they want to see grow rapidly with the help of a modernized FDA approval process.

GDUFA faces congressional approval again in 2017.

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