Woodcock to Congress: FDA Is Not a Drug Price Regulator, GDUFA Progress on Track

The FDA is not in the business of regulating drug prices, CDER Director Janet Woodcock told a Senate committee Jan. 28, pushing back against criticism that the FDA should tackle rising drug prices.

Several senators proposed ideas of how the agency might control prices — particularly orphan generics with no competition — but Woodcock demurred, emphasizing that the agency’s focus is on safety and efficacy, not dollars and cents.

While the Senate HELP committee hearing was intended to focus on the FDA’s handling of ANDAs following the 2012 passage of GDUFA — and part of the discussion did address the topic — much of the conversation centered on the current furor surrounding an absence of price caps on generic drugs.

“We’re scientists,” she told Sen. Sheldon Whitehouse (D-R.I.) when he asked if the agency was trying to define the “market failure” that enables companies to purchase the rights to drugs with no competition and then raise the price a thousand-fold. “For pricing issues, HHS is better suited than the FDA.”

Sen. Elizabeth Warren (D-Mass.) received a similar reaction when she asked whether the FDA tries to rush generic competition to market when a company suddenly hikes the price of one of its uncontested drugs.

“We don’t have the expertise to determine” what constitutes a price spike, Woodcock explained. “Is it a pill that cost 10 cents and now costs 30 cents, or is it when it costs 10 cents and now costs $875?”

“That sounds a little price spikey to me,” Warren interjected with a laugh.

Woodcock added that there are legal ambiguities to the agency taking such action, given the volume of lawsuits surrounding generic drug rights, but conceded that “it might be possible if there were some bullet-proof definition of what a ‘price spike’ is.”

Sen. Al Franken (D-Minn.) asked if the FDA would be willing to permit mass compounding as a means to undercut overpriced generics, but Woodcock noted that “there are very great risks” with such an approach.

She highlighted two recent incidents of improperly compounded medications, noting that one involved multivitamins that gave some patients kidney failure, while another was a hormone compound that was 1,000 times more potent than it should have been, which also led to hospitalizations. “[A] mass production of drugs under uncontrolled conditions … could put thousands in the hospital,” she warned.

Working Through the Backlog

Other senators asked about the agency’s progress since the passage of GDUFA, the intended focus of the hearing.

Under questioning by Committee Chairman Sen. Lamar Alexander (R-Tenn.), Woodcock admitted that the FDA had fallen behind with processing ANDAs and conducting inspections at foreign facilities prior to GDUFA’s passage. However, “in the three years since GDUFA’s passage, FDA has met, and in many cases, exceeded, all GDUFA goals established.”

When Sen. Bill Cassidy (R-La.) asked why the agency still has a backlog of 3,500 ANDAs from before GDUFA’s passage, Woodcock explained that this is because the FDA lacked a system at the time for ensuring review dates were met, and that the agency is slowly working its way through all of them.

Woodcock also put some of the onus on industry, noting that many ANDAs are rejected because of insufficient information or low-quality data.

“We’ve gotten applications where they’ve just cut and pasted [the contents] from other applications,” she added.

She also promised Sen. Orrin Hatch (R-Utah) that the FDA would clear out the backlog prior to the expected renewal of GDUFA in fiscal 2018. — Cameron Ayers


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