FDA reauthorization bill sails through Senate

Showing unusual bipartisan spirit, the Senate passed a massive FDA user-fee reauthorization bill Thursday designed to prevent drug shortages and speed federal approval of medicines, including lower-cost generic versions.

Politico: FDA User Fee Bill Passed By Senate
With little bickering and no effort to repeal the Obama administration's health reform law, the Senate passed the massive Food and Drug Administration Safety and Innovation Act on Thursday well ahead of schedule. ... The $6.4 billion, five-year reauthorization of FDA-industry user fee agreements partially funds the agency's review of drugs and medical devices, which would have expired at the end of September without action. Previous user fee authorizations have been contentious affairs. But notwithstanding the election-year and health care politics that dominate Congress, the bill sailed through with hardly a complaint (Norman, 5/24).

The New York Times: Senate Backs Bipartisan Bill To Speed Drugs And Avert Shortages
The Senate passed a major bipartisan bill on Thursday to prevent drug shortages and to speed federal approval of lifesaving medicines, including lower-cost generic versions of biotechnology products. A similar bill is on a fast track to approval in the House, perhaps as early as next week. President Obama, consumer groups and pharmaceutical companies strongly support the legislation (Pear, 5/24).

The Hill: Senate Passes FDA Reauthorization
Senate Majority Leader Harry Reid (D-Nev.) said the bill's passage was how all legislation should move through the Senate. "I know people are anxious to move on and I am too but I have to say just a word," Reid said after the vote. "I have already said in my caucus how much I appreciate the work of Sen. Enzi. He is a fine senator. He and Sen. Harkin have worked so well together on this. It's exemplary for what the rest of us should do" (Strauss, 5/24).

The Hill: Senate Republicans Criticize Obama As Drug Reimportation Amendment Fails
Republicans are slamming President Obama for his silence on drug reimportation legislation, claiming he has broken his campaign promise to allow seniors to buy cheaper medications from other countries. The pharmaceutical industry strongly opposes the idea, which failed again in the Senate on Thursday. Reimportation was kept out of the 2003 bill that created Medicare Part D and the 2010 healthcare law, though as a senator, Obama had co-sponsored a measure to allow it (Viebeck, 5/24).

Modern Healthcare: Senate OKs Measure To Reauthorize User-Fee Programs
The Senate easily passed a reauthorization of the Food and Drug Administration's drug and device user-fee programs and authorized new generic and biosimilar user-fee programs. The 96-1 vote to pass the measure followed a series of close votes that crossed partisan lines in which the chamber rejected a series on amendments, including one to allow the importation of pharmaceuticals from Canada (Daly, 5/24). 

MedPage Today: Senate Passes Drugmaker User Fee Bill
One piece of the massive FDA user fee legislation would reauthorize the Prescription Drug User Fee Act (PDUFA), the popular program that charges drug companies fees that help fund the FDA's drug approval programs. Since PDUFA was first passed in 1992, it has become the major revenue stream for the FDA's drug review programs, with user fees funding 62% of the agency's drug review expenses in 2010. Funding from PDUFA also has enabled the agency to hire more staff, and it has been hailed as a success by those who point to the shorter drug review times after PDUFA (Walker, 5/24).

Minneapolis Star Tribune: Congress Acts To Ease Shortages Of Vital Drugs In FDA Overhaul
Axel Zirbes' doctor said his leukemia required cytarabine, a standard chemotherapy drug that attacks cancers of the white blood cells…. That set the family on a nationwide scramble to find a dose -- a quest repeated by thousands of other families in Minnesota and around the country. It also touched off pleas for help to lawmakers like U.S. Sen. Amy Klobuchar, D-Minn., one of several who took up their case in legislation approved Thursday in the Senate. The provision, which requires drugmakers to issue warnings of looming drug shortages, also has been written into a bill expected to clear the House next week (Diaz and Spencer, 5/24).