Passing FDA bill will save lives

As work in our nation’s capital slowly grinds to a halt because of election-year politics, several members of Congress are quietly working on bipartisan legislation that will help patients, create jobs and save lives. 

The legislation reauthorizes the Food and Drug Administration’s (FDA) user-fee programs and ensures that Americans get better access to safe, innovative medicines and medical devices. Ezra Klein’s Wonkblog has called it the most important health policy that Americans have never heard of, and in addition to bipartisan support in Congress, the bill enjoys broad support from the biomedical industry, patient groups, consumer groups and other stakeholders. 

 Last month, the Senate Health, Education, Labor and Pensions Committee overwhelmingly approved this bipartisan legislation. In addition to helping provide better access to new life-saving medicines and devices, the measure will modernize how the FDA inspects foreign facilities to better account for the global nature of drug manufacturing and allow the FDA to prioritize and target riskier overseas manufacturers. This will help prevent problems with counterfeit drugs, like the one in 2007 involving a blood-thinning drug manufactured in China that led to the deaths of several American patients. In addition, this will ensure that foreign manufacturers are subject to the same regulatory oversight as domestic manufacturers, leveling the playing field for U.S. medical product manufacturers.  


 This legislation also helps reduce prescription drug costs for consumers by speeding the approval of lower-cost generic drugs. By providing FDA with additional resources to review and approve new generic versions of popular drugs, including expensive biologic products, competition will increase and costs will go down. These provisions will also help FDA address recent problems with drug shortages, allowing it to inspect and approve new manufacturing facilities on an expedited basis and improve FDA’s access to information about potential shortages before they happen. 

 The bill will also improve how FDA does business. It will provide for greater accountability and transparency in FDA’s decisions, speed approval of innovative products and give manufacturers more predictability and consistency. These changes will allow U.S. manufacturers to better compete in the global marketplace and promote more drug development and manufacturing here in the United States.

The failure to reauthorize the drug and device user-fee programs before they expire this fall will threaten biomedical industry jobs, patient access to new therapies and America’s global leadership in biomedical innovation. That is why we have worked so hard to focus on those measures that can enjoy broad, bipartisan support and tried to set aside those issues that, by their nature, would divide us. 

 Passing this important legislation will provide thousands of Americans with access to life-saving medicines and medical devices, and show that Congress can still function when it comes to critical life-and-death issues like this one. It is our hope that members on both sides of the aisle can set aside the heated rhetoric and support this bipartisan measure. Rarely does Congress have the opportunity to pass such significant legislation that can literally save the lives of thousands of Americans across the country. We look forward to proving that even during an election year, Congress can still carry out its most important function — by passing bills that matter.

Harkin and Enzi are the chairman and ranking member, respectively, on the Senate Health, Education, Labor and Pensions  Committee.