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PDUFA Package Continues Its Roll Through Congress

By Mari Serebrov
Washington Editor

WASHINGTON – Drugmakers are keeping their fingers crossed as two separate bills to reauthorize PDUFA roll through Congress well ahead of its Sept. 30 expiration.

S. 2516 may advance to the Senate floor as early as this week, and the House is expected to bring H.R. 5651 to the floor late this month. However, several proposed amendments, ranging from a curb on pay-for-delay settlements to importation of drugs from Canada, could stall the bills and hamper agreement between the two chambers.

The last time PDUFA came up for renewal, irreconcilable differences between the House and Senate delayed passage until almost the midnight hour. This time, the bills are fairly similar – for now. If a controversial amendment is added in either chamber, reconciliation will be that much harder. (See BioWorld Today, Sept. 4, 2007.)

One notable difference in the two bills is the incentives for new antibiotics. S. 2516 would limit the five-year exclusivity incentive to new antibiotics that target serious or life-threatening diseases, whereas the House version is much more expansive. Rep. Henry Waxman (D-Calif.) cited that broad wording as one of the points of contention that needed to be worked out before the House Health Subcommittee marked it up. Apparently, it wasn't a dealbreaker, as the wording was included in the bill passed by the subcommittee and the Energy and Commerce Committee. (See BioWorld Today, April 27, 2012.)

Whichever version of PDUFA is signed into law, it's bound to impact the federal deficit. As drafted, the Senate bill would reduce the deficit by $71 million from 2013 through 2017 by lowering the average cost of prescription drugs and, thus, insurance costs, according to the Congressional Budget Office (CBO). Over the next decade, the bill would produce $363 million in savings, while increasing federal revenue by $5 million.

Under the bill, the FDA is expected to assess about $4.6 billion in drug and device user fees over the next five years, the CBO said. Of that, $1.8 billion would come from accreditation activities and the new fees for generic drugs and biosimilars. The increased fees for devices and brand drugs are expected to generate about $4.7 billion from 2013 through 2017.

As a comparison, the CBO noted that the FDA will collect about $760 million in fiscal 2012 under PDUFA IV, which authorized user fees only for brand drugs and devices.

In addition to the user fees, S. 2516 would impose a number of new mandates on industry, the CBO said. For instance, the bill would:

require early notification of circumstances that could lead to a drug shortage;

require drugmakers to notify the FDA before discontinuing production of certain products;

increase reporting requirements for drugmakers granted a deferral or extension for required pediatric studies;

expand registration requirements on certain entities involved in the manufacture, preparation, propagation, compounding or processing of drugs;

remove the loophole, created by risk evaluation and mitigation strategies, that some drugmakers used to prevent the sale of a drug to manufacturers developing generic or biosimilar versions.

The CBO has yet to score the House bill.

Prizes, Not Patents

A Senate subcommittee hearing on offering prizes instead of patents for new HIV/AIDS drugs was so off the radar screen for most lawmakers that Sen. Bernard Sanders (I-Vt.) was the only senator who showed up Tuesday.

In opening the hearing, Sanders acknowledged that his controversial bill, S. 1138, which has been sitting in the Senate Health, Education, Labor and Pensions Committee for nearly a year, doesn't have a chance of being passed in the next few months. But he hoped that the more people understand it, the more support it will get.

"For the United States Congress, this is a fairly radical piece of legislation," Sanders said, countering that the idea of a prize fund for drug development is not radical; it's commonsensical.

S. 1138 would create a $3 billion prize fund to be divvied up among developers of new HIV/AIDS treatments and prophylactics – so long as the drugs and vaccines are not exclusively patented. The proposal, which Sanders would like to see as a model for other drugs, would break the link between drug prices and rewards, resulting in new medicines that offer new benefits, rather than me-too drugs, he said.

The motivation for the prize fund is the high price of drugs in the U.S., which Sanders called a significant barrier to access to health care. He noted that U.S. drug prices are on average 85 percent higher than those in Canada and 150 percent higher than in France, Italy, Sweden and Switzerland.

What spurred his focus on HIV/AIDS drugs was the inequity in pricing in the U.S. and developing countries for the same drug. He said Gilead Sciences Inc.'s Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) costs more than $25,000 per person per year in the U.S., whereas a generic, FDA-approved version of the same drug is being purchased by the President's Emergency Plan for AIDS Relief for less than $200 per patient per year for distribution in developing countries.

HHS Targets Alzheimer's Treatments

2025 is the Department of Health and Human Services' (HHS) target date for developing effective preventive measures and treatments for Alzheimer's disease.

To hit that target, HHS has set its sites on a national plan, revealed this week, that includes research, clinician tools, public awareness and caregiver support.

One of the first steps is a boost in funding for two Alzheimer's trials. The National Institutes of Health kicked in $7.9 million for a trial testing an insulin nasal spray to treat patients with Alzheimer's and $16 million for the first prevention trial in people at the highest risk of the disease.

The administration's fiscal 2013 budget proposal calls for an additional $100 million in funding for Alzheimer's with about $80 million to be used in research.