WASHINGTON – With none of the debate seen in the Senate over a string of amendments, the House overwhelmingly voted Wednesday to suspend the rules and pass its revised PDUFA package that purportedly will save the federal government $370 million over the next decade.
Now the FDA Reform Act, H.R. 5651, will move to conference to be reconciled with the FDA Safety and Innovation Act (FDASIA), which passed the Senate last week. Both chambers want to have PDUFA reauthorized by July 4. (See BioWorld Today, May 25, 2012.)
The last time the user fee package 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. (See BioWorld Today, Sept. 4, 2007.)
The PDUFA V package passed by the House was amended late last week after the Congressional Budget Office (CBO) estimated it would increase the budget deficit by $247 million by 2022 – $244 million in direct government spending and $3 million in loss of revenue. (See BioWorld Today, May 29, 2012.)
To create the savings, Rep. Fred Upton (R-Mich.) expanded a provision that reduced the FDA's 180-day deadline for a citizen petition requesting a stay on a pending generic drug application to cover biosimilars as well. The amended bill gives the agency 150 days to respond to petitions involving generics or biosimilars.
Since the FDA has no deadline now for petitions related to biosimilars, the change could speed the process of introducing competition, thus lowering the cost of biologics sooner.
The tweak brings the House bill financially in line with the $368 million in savings and revenue the Senate FDASIA is expected to generate, according to the CBO. (See BioWorld Today, May 16, 2012.)
Among other provisions to be reconciled are the definition of new antibiotics that will be eligible for five-year exclusivity and the regulation of synthetic drugs. FDASIA limits the exclusivity incentive to new antibiotics that target serious or life-threatening diseases, whereas the House version would allow a broader range of antibiotics to qualify for the incentive.
The Senate bill also includes an amendment that adds a number of synthetic drugs to the Controlled Substances Act. While the House PDUFA bill doesn't contain a similar provision, the House passed a stand-alone bill, H.R. 1254, in December to address the synthetic drug problem. That bill has been sitting in the Senate Judiciary Committee since Dec. 18.
Before the vote Wednesday, Rep. Michael Burgess (R-Texas) acknowledged the House bill wasn't perfect. But "we've come awfully close to getting it right," he said.
Rep. Frank Pallone (D-N.J.) praised the bipartisan effort that produced the bill, saying it is an important bill – important for patients and for job creation.
Rep. Joseph Pitts (R-Pa.) agreed, adding that it will help the U.S. continue to be a world leader in medical innovation.
More Counterfeits in U.S.
Another counterfeit drug has made it into the U.S. by way of the Internet. This time, it's a knockoff of Teva Pharamceutical Industries Ltd.'s Adderall 30-mg tablets, a controlled substance that's in short supply and that requires special controls for dispensing.
Adderall, approved to treat attention deficit hyperactivity disorders and narcolepsy, contains dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. While the packaging for the counterfeit claims to have the same active pharmaceutical ingredients (APIs), the FDA's preliminary lab tests showed it contains tramadol and acetaminophen, which are used to treat acute pain.
The FDA warned that rogue websites and distributors may target drugs in short supply for counterfeiting.
Although it wasn't in shortage, Genentech Inc.'s cancer drug Avastin 400 mg/16 mL fell prey to counterfeiters earlier this year. The counterfeits were purchased by some U.S. medical practices, along with other unapproved cancer drugs. As with Adderall, the counterfeit didn't contain Avastin's API bevacizumab. (See BioWorld Today, Feb. 16, 2012.)