Wall Street Journal : FDA vote this week

Lawmakers To Vote On FDA Clout

by Thomas M. Burton  Wall Street Journal Saturday/Sunday, May 19-20, 2012 (FiDA blog added bold.)

New Prescription

The legislation proposing to renew regulations for pharmaceuticals and medicla devices would:

• Make it easier for federal regulators to inspect overseas drug-ingredient makers
• Require drug makers to warn authorities early if they expect drug shortages
• Set a deadline to create a new system to track safety problems with medical devices

The Senate could vote as soon as next week on whether to give the Food and Drug Administration broader regulatory authority, including new powers to prevent prescription drug shortages, inspect overseas drug facilities and more closely track medical devices for safety flaws.

The legislation, which is expected to pass, would renew a broad law that determines how much drug companies and medical-device makers pay the FDA to review their products. 

brand name drug companies are expected to pay about $4billion in user fees over the five-year law, an increase of about 6% from the current law.  Medical device companies would pay about $600 million over the same period, which is about double the current rate.

Under the proposed legislation, the generic drug industry would, for the first time, pitch in about $1.5 billion in user fees to pay for faster product reviews.  Also new are proposed user fees for companies making "biosimilar" drugs or knock-offs that could mimic complex drugs such as erythropoietin for anemia and Herceptin for cancer.  

Lawmakers say the effort has prompted little partisan sparing. A version of the legislation moving through the House is largely similar to the Senate's.

Still, drug makers are concerned Congress could get stalled and not pass a final bill before the current law expires Sept. 30.  That would leave the agency without funding and "have catastrophic effects on the FDA's ability to carry out its essential function," said Matthew Bennett, a senior vice president at the Pharmaceutical Research and Manufacturers of America.

J.C. Scott, chief lobbyist for medical device trade industry group AdvaMed, said the industry is concerned about a Senate provision that would make it far easier for the FDA to subject class of medical devices to more intensive clinical studies.

But the group supports the bill and has successfully won provisions requiring the FDA to have more meet ins with companies to keep them informed while their devices are going through the approval process.

In both the House and Senate versions of the legislation, some of the most important powers of the FDA would gain involve regulatory authority of foreign raw materials for drugs.  About 80% of the raw material used in drugs now comes from overseas, especially China and India.  Currently, the FDA has limited ability to require safety inspections of foreign drug facilities. This hampered the agency's response to gained heparin blood=thinner derived from China in 2008.  In that incident, 81 patients died an the agency wasn't able to discern where adulteration of the medicine occurred.

Both the House and Senate bills wood give the agency power to block products' entry into the U.S. if the FDA were refused admission to fully inspect facilities, and put the burden on companies to ensure the integrity of their supply chains.  Also, the FDA would get the authority to fix a huge disparity: that U.S. plants are inspected about every two years, and ones overseas every nine years.  Te legislation would give the FDA broad discretion to focus on the most risky products, anywhere in the world.  

"FDA's current drug-safety authorities are decades old and were never intended to address todays global market," said Deborah M. Autor, the agency's deputy commissioner for global regulatory operations.

The FDA has struggle to avert shortages of prescription drugs. The agency often doesn't know of production shutdowns that can lead to shortages until too late.  The Senate and House bills would require manufacturers to notify the agency early on if they believe a shortage is about to happen.