Lawmakers set to address prescription drug plan

Two weeks after the Food and Drug Administration (FDA) submitted draft legislation for reauthorizing a prescription-drug user-fee program — and two weeks before Congress begins to tackle the bill in earnest — lawmakers are mum on the agency’s proposal.

The FDA proposal, drafted in conjunction with the pharmaceutical and biotechnology industries, is expected to serve as the basis for the reauthorization of the Prescription Drug User Fee Act (PDUFA), a program through which drug makers pay the FDA to review new products.

The FDA transmitted draft legislation to Congress on March 16, but key lawmakers have yet to make public statements endorsing or criticizing the agency-industry PDUFA proposal.

Pharmaceutical companies, meanwhile, are satisfied with the proposal but anxious that the bill could become a vehicle for other drug-related legislation they oppose.

“Are we concerned that these things will be piled on to PDUFA? Absolutely. We would hope the Congress would be very careful about not ‘Christmas-treeing’ PDUFA to the point where it can’t pass,” the president and chief executive of the Pharmaceutical Research and Manufacturers of America (PhRMA), Billy Tauzin, said.

The Biotechnology Industry Organization (BIO) wants to prevent PDUFA from becoming “encumbered with unrelated or scientifically contentious issues,” the group’s director of science and regulatory affairs, Andrew Emmett, said.

As required by statute, the FDA developed its proposal through negotiations with drug and biotech companies, which were represented by PhRMA and BIO.

The House Energy and Commerce and Senate Health, Education, Labor and Pensions (HELP) committees are slated to take up PDUFA soon after the April congressional recess, with the goal of completing the process before the August recess because the law expires on Sept. 30.

Energy and Commerce Committee Chairman John Dingell (D-Mich.) “is going to reserve judgment,” a spokeswoman said. “We want to allow our members a chance to learn more about the proposal.”

Dingell is determined to complete PDUFA and other prescription-drug and medical-device legislation and avoid disrupting the FDA, which could be forced to furlough or lay off employees whose salaries are financed by PDUFA dollars if Congress does not act in time, the spokeswoman said. The panel’s Health Subcommittee will hold a hearing on PDUFA shortly after the April recess.

HELP Committee Chairman Edward Kennedy (D-Mass.) has committed in the past to a similar timeframe. His office did not respond to a request for comment on the FDA’s PDUFA proposal by press time.

“The Prescription Drug User Fee program is a successful partnership between industry and the Food and Drug Administration (FDA), and we should move quickly to reauthorize it,” HELP Committee ranking member Mike EnziMike EnziLive coverage: Senate debates repealing ObamaCare Overnight Finance: House votes to repeal arbitration rule | Yellen, Cohn on Trump's list for Fed chief | House passes Russia sanctions deal | GOP centrists push back on border wall funding Senators urge quotas on Canadian lumber, consultations with Congress MORE (R-Wyo.) said in a written statement.

Enzi’s spokesman confirmed that the panel’s Democratic and Republican staffs are working together on a PDUFA bill that is likely to include new drug-safety legislation and a medical-device user-fee bill.

Under the FDA’s proposal, the agency would receive $392.8 million in user fees each year, which represents an $87.4 million increase over the current formula. About a third of the new money — $29.3 million — would go toward bolstering the agency’s ability to track the safety of medicines after they reach the market.

Unlike the drug industry, leading consumer groups are dissatisfied with the proposal. Although the agency held a public meeting in February on a draft of its proposal and accepted written comments during the process, representatives of consumer groups did not have a seat at the table with drug makers, a senior policy analyst at Consumers Union, Bill Vaughan, said.

Consumers Union believes the FDA proposal does not include sufficient funds for monitoring the safety of drugs once they are approved and enter the marketplace, Vaughan said.

FDA monitoring of the post-market safety of drugs has garnered intense criticism from Congress and consumer groups in recent years, especially since Merck pulled its blockbuster drug Vioxx in 2004 after evidence linked it to serious and fatal side effects.

Kennedy and Enzi are cosponsors of a bill aiming to beef up the FDA’s authorities in this area, in part by requiring the agency, and the drug companies, to establish a post-market safety plan for a drug before it is approved.

“There are some very good drug safety ideas in the PDUFA proposal, but it lacks new authorities for FDA. The Enzi-Kennedy bill is a reasonable proposal to add new authorities in order to improve drug safety and restore public confidence in the agency,” Enzi said.

Democratic Reps. Henry Waxman (Calif.) and Edward MarkeyEd MarkeyUS, South Korea talk military options following North Korea missile test OPINION | Shailene Woodley: US should run on renewable energy by 2050 Dems urge 'transparent and inclusive' nuke policy review MORE (Mass.), both senior Energy and Commerce Committee members, have cosponsored a similar but wider-reaching bill. Dingell is reviewing the legislation, his spokeswoman said.
“We are certainly not opposed to drug safety legislation,” BIO Vice President for Science and Regulatory Affairs Sara Radcliffe said, but the group believes attaching a bill such as Kennedy-Enzi to PDUFA would be premature.

Tauzin said PhRMA has not taken a position on the Senate drug-safety bill. “It all depends on what Kennedy-Enzi looks like at the end,” he said, noting that drug makers have concerns about the bill, including whether it would allow only medical specialists to prescribe certain medicines.

Although PhRMA may be holding its fire over the drug-safety bills, the industry is drawing a bright line against the inclusion of legislation that would give the FDA new authorities to approve generic versions of biological drugs, which the industry calls “biosimilar” drugs or “follow-on biologics” because the new medicines would not be identical to their brand-name forebears.

“We’re deeply concerned that this not be just a political football, something tagged on to PDUFA or anything else,” Tauzin said.