Senate Passes FDA User Fee Bill

Senate Passes FDA User Fee Bill

In a rare display of bipartisanship, the U.S. Senate has passed the Food and Drug Administration Safety and Innovation Act. The vote was 96-1. Sen. Bernie Sanders (I-Vermont) was the only no vote.

The $6.4 billion legislation reauthorizes FDA user fee agreements with industry and funds the agency’s review of drugs and medical devices, which would expire at the end of September without action.

The bill is strongly supported by the pharmaceutical and medical device industries. One congressional staffer told American News Report that was because “the pharmaceutical industry wrote most of it.”

“We’ve worked on this bill for 18 months,” said Senate Health Committee Chairman Tom Harkin (D-Iowa), who joined with Sen. Mike Enzi (R-Wyoming) to defeat several attempts to add amendments to the bill.

Two such amendments were strongly opposed by the pharmaceutical industry.

Sen. Sanders wrote an amendment that would take away exclusive marketing rights from drug makers if they were found guilty or admitted to fraud in marketing a particular medicine. Sanders said there was a “culture of fraud” in the industry, but his measure failed on a 9 to 88 vote.

“The most pressing prescription drug issue in our country today is that Americans pay, by far, the highest prices in the world for their medicine and millions of people cannot afford the medications their doctors prescribe,” Sanders said in a statement. “I voted against this bill because it does far too little to address this crisis while it perpetuates a prescription drug system that continues to fail the American people.”

Sen. John McCain (R-Arizona) led another effort to allow Americans to import low cost prescription drugs from Canadian pharmacies. “What we’re about to see is the incredible influence of special interests here, particularly Pharma,” McCain predicted before his amendment was defeated, 54 to 43. Sixty votes were needed.

Consumer advocates have mixed feelings about the Senate bill and a similar version the House is expected to begin debate on next week. Consumer groups had lobbied hard for lawmakers to close a loophole that allows medical device manufacturers to sell products similar to ones withdrawn from the market because of safety concerns – without being required to prove that design flaws in the new devices have been fixed. More than 90 percent of medical devices do not require clinical testing before the FDA clears them for sale if they are “substantially equivalent” to earlier versions.

The Senate bill does address a number of concerns about the safety and quality of imported drugs. Under the legislation, the FDA would get new powers to police imported drug ingredients and inspect overseas facilities. About 80 percent of the ingredients used in U.S. medicines come from overseas.

Under the bill, drug makers would also be required to report production problems that could lead to drug shortages – which have been a persistent problem for hundreds of medicines.

House and Senate leaders want to finish the bill and deliver it to President Barack Obama by early July.

Authored by: Pat Anson, Editor