By U.S. Sen. Michael Bennet
The laws governing the nation’s pharmaceutical industry are in desperate need of an update. The Food and Drug Administration (FDA) and its laws were designed to regulate a supply chain, from medicine makers to consumers, that was based in the 48 contiguous states.
Today we live in an era where over 80 percent of the active ingredients in our pharmaceuticals are manufactured abroad. Current law forces the FDA to inspect American facilities every two years, but there are no mandates on how often it inspects facilities overseas. The Government Accounting Office has found that the FDA can only keep pace with inspecting the most high-risk overseas facilities once every nine years. These pharmaceuticals ultimately end up being used to treat our families.
Patients have no idea whether the ingredients in their drugs were made in China, India or if they were ever inspected. Our American manufacturers are operating on an uneven playing field. Those who operate in the United States have to expect a surprise FDA inspection every two years on average. Meanwhile, their foreign counterparts do not have to worry about the FDA visiting them for a decade.
To remedy this, in a rare and exceptional moment of bipartisanship, the Senate and the House in consecutive weeks in late May passed an FDA reform bill. This bill would implement a risk-based inspection schedule for both foreign and domestic manufacturing sites. It would make sure that drug manufacturers know what is in their supply chain every step of the way. And for the first time, if you manufacture abroad and refuse or delay inspection without good reason, the FDA can refuse to let your product into this country.
These are all steps American families already think we have in place to protect them. I cannot tell you how many town halls I have had where people have been shocked to learn that the products they have in their medicine cabinets have never been inspected by anyone. This bill will change that. It is a thoughtful, commonsense approach that virtually all of the constituents in this debate support.
Another very exciting part of this bill is that the FDA will now apply 21st-century science to the approval of drugs, particularly drugs that are “breakthrough” medications. It will give the FDA flexibility to expedite groundbreaking drugs or treatments that show dramatic responses early in development, while still ensuring drug safety and efficacy. This is important to patients with cancer, Alzheimer’s, ALS and a litany of other critical, life-threatening diseases who are looking to access these breakthrough therapies.
Working to reform the FDA has been a remarkable process. The conversation in Washington is usually decoupled from the conversations that the people in my state are having around their kitchen tables about the challenges we need to address. The gap has traditionally been a mile wide. Yet, the debate on the FDA bill allowed me and members of Congress who worked on the bill to be responsive to what our constituents say they want: a modern FDA with improved patient safety and innovation.
The FDA user fee bill will help patients and consumers access safer medicine more efficiently and is a major boost for the bioscience community, which is a leading source of innovation and economic development in Colorado and across the country.
Michael Bennet is a U.S. Senator from Colorado.