Drug Pricing Among Senators' Questions for FDA Nominee

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By Bronwyn Mixter

Nov. 17 — Even though the FDA doesn't make policy affecting drug prices, some senators Nov. 17 asked the Obama administration's nominee to lead the agency about the issue.

During his Senate confirmation hearing, Robert Califf also was asked about his ties to the drug industry and the slow approval times for generic drugs. At the Senate Health, Education, Labor, and Pensions (HELP) Committee hearing, most senators indicated that they supported Califf's confirmation.

However, Sen. Bernie Sanders (I-Vt.), a Democratic presidential candidate, said he would oppose Califf's confirmation because he isn't “strong enough” on the issue of drug prices. Califf pointed out that the Food and Drug Administration doesn't set drug prices. However, Sanders said drug lobbying does affect drug prices and “we need a commissioner who is going to stand up to the pharmaceutical industry and protect American consumers. You are not that person.”

Sanders also asked Califf whether he supports the reimportation of less expensive drugs from Canada. Califf said the agency has “major concerns about reimportation” and while “we have the capability,” it would add additional costs. Sanders also asked Califf about whether he supports the right of Medicare to negotiate drug prices and Califf said he did “in certain circumstances.”

Since January, Califf has been deputy FDA commissioner for medical products and tobacco. Before that, he was founding director of Duke's Clinical Research Institute. He would succeed Margaret Hamburg, who stepped down at the end of March. Stephen Ostroff, the agency’s former chief scientist, has served as acting commissioner since then.

The Senate HELP Committee will next vote on whether to confirm Califf.

Generic Drug Backlog, Approvals 

While Sen. Lamar Alexander (R-Tenn.), chairman of the committee, said at the hearing that he doesn't expect Califf's nomination to be held up, he also questioned Califf about drug prices.

“The FDA's job, of course, is not to set drug prices,” Alexander said. “It is to make sure that drugs are safe and effective. But the FDA can help the market lower drug prices by approving generic drugs and other products as quickly as it possibly can, so there is more choice and competition in the market.”

Alexander questioned Califf about the backlog of generic drug applications and slow generic drug approvals. He said that despite getting $1 billion in new funds from the generic drug industry in 2012, the median approval time for generic drugs went from 30 months in 2011 to 48 months in 2014.

Califf said the FDA is ahead of its Generic Drug User Fee Amendments (GDUFA) goals, “but we can still do better.” He said the agency started with a huge backlog and some of the applications aren't complete or the agency has questions about manufacturing issues. He said that once the backlog applications are complete, he's confident the applications will be approved more quickly.

GDUFA was enacted as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 (10 PLIR 891, 7/13/12). FDASIA authorizes GDUFA for a five-year period from Oct. 1, 2012, through Sept. 30, 2017. Under GDUFA, generic manufacturers pay fees to the FDA for quicker reviews for their applications. New legislation is required to reauthorize GDUFA after Sept. 30, 2017.

Drug Monopolies 

Sen. Bill Cassidy (R-La.) said Turing Pharmaceuticals “abused the social contract” when it increased the price of Daraprim.

After acquiring the anti-parasitic drug Daraprim, New York-based Turing implemented the price increase. The treatment, the only federally approved drug for a particular complication of AIDS and cancer, was raised from $13.50 to $750 per pill.

Cassidy said it would take the FDA “several years” to approve a generic version of Daraprim and “we have to come up with a more efficient way to do generics.”

Califf said later in the hearing that while the FDA keeps track of drug shortages in order to prevent them, a new area the agency has to work on is when someone gets a monopoly on a drug product.

Ties to Drug Industry 

Sen. Elizabeth Warren (D-Mass.) said that during Califf's time at Duke, he received financial backing from the pharmaceutical industry for clinical trials that he oversaw and asked what input pharmaceutical sponsors had on the trials.

Califf said that when the pharmaceutical industry funds a clinical trial, the contract guarantees the independent right to publish the results and pharmaceutical companies can't make changes to what's published.

Warren said she has requested copies of contracts between drug companies and Duke researchers. She also said many drug and device companies say the FDA's standards are too high and should be lowered.

“I think if you look at my record you'll find I've never been a proponent of lowering standards,” Califf said.

Laboratory-Developed Tests 

Sen. Richard Burr (R-N.C.) asked Califf how he would ensure the “regulation of laboratory-developed tests in a workable way.”

“I'm well aware of the importance of laboratory-developed tests,” Califf said. “On the other hand, this has become a big industry” and “we're committed to working with the whole ecosystem so there is a standard for these tests.”

The Centers for Medicare & Medicaid Services regulates laboratory-developed tests (LDTs), while the FDA's Center for Devices and Radiological Health (CDRH) regulates certain in vitro diagnostic (IVDs) tests, or those tests manufactured by device companies. In the fall of 2014, the FDA issued two controversial draft guidance documents to exert more authority over LDTs, a move that clinical labs and some other medical groups oppose but that device manufacturers have supported.

The House Energy and Commerce health subcommittee held a hearing Nov. 17 on the future regulation of lab-developed tests.

Pathway for Combination Products?

Sen. Sheldon Whitehouse (D-R.I.) said there are products emerging that combine drugs and devices and questioned whether the FDA needs a new pathway for the approval of these combination products.

Whitehouse also asked how long it would take the FDA to come up with a proposal for the new pathway if it is needed.

Califf said a new pathway is needed and the FDA could come up with a proposal on this for Congress within the next year.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Janey Cohen at jcohen@bna.com

More information on the hearing is available at http://www.help.senate.gov/hearings/nomination-of-dr-robert-califf-to-serve-as-fda-commissioner.