Includes Bennet Measures to Improve Drug Safety, Bring Breakthrough Treatments to Patients Quicker, Advance Medical Device Innovation and Avoid Critical Drug Shortages
The U.S. Senate today began debate on a bipartisan bill to reauthorize the Food and Drug Administration (FDA). The bill includes several Bennet provisions aimed at improving drug safety, bringing breakthrough treatments to patients more quickly, advancing medical device innovations and preventing critical drug shortages.
“This important bill will help modernize the FDA, drive innovation in the bioscience industry, and establish protections for the care and safety of Colorado’s patients,” said Bennet. “I commend my colleagues on the Senate HELP Committee for their bipartisan work through each step of this process. The improvements in this bill will help the FDA address record recalls and drug shortages and provide quicker access to new drugs and therapies. I hope we can have a fair debate and pass this bill quickly.”
The FDA Safety and Innovation Act reauthorizes FDA user fee agreements, which began in 1992. FDA’s budget largely depends on industry-paid user fees to supplement Congressional appropriations. This year, Congress plans to reauthorize four user fee agreements to provide additional resources pertaining to prescription drugs, medical devices, generic drugs and biosimilars. The FDA Safety and Innovation Act contains these user fee agreements as well as a number of additional policy provisions aimed at updating FDA regulations to improve care for patients and families in Colorado and across the country.
User fee agreements are negotiated between FDA and the affected industries and then sent to Congress for authorization. The prescription drug and medical device user fees included in this bill will expire in September if Congress does not reauthorize them. The generic drugs and generic biologics, or biosimilars, user fees are newly authorized in this bill.
These user fee agreements will provide more certainty to Colorado’s growing bioscience industry. About 20,000 Coloradans work at more than 400 companies in the bioscience industry, which amounts to $7 billion in payroll in Colorado alone.
Bennet secured several provision in the bill during the committee process. Additionally, he worked with Senators Tom Harkin, Mike Enzi and Orrin Hatch to include a bipartisan measure to ensure input from stakeholders such as emerging technology companies in the rapidly growing field of medical apps for mobile devices.
Last year, the FDA issued a draft guidance that indicated it would regulate an array of medical mobile applications as medical devices. Since then, Bennet has heard from software, technology and insurance companies as well as patient groups in Colorado and across the country regarding a lack input and lack of clarity on the draft guidance, in particular on medical smartphone apps and on the larger regulation of health information technology.
Bennet’s provision would require the Department of Health and Human Services and an outside working group to review these regulations more carefully and report to Congress to clarify what applications should be and should not be regulated. The amendment also would create a panel of experts and stakeholders to suggest a new regulatory framework for innovative health information technologies, including mobile medical applications. Bennet worked closely with cosponsor Senator Orin Hatch (R-UT) and HELP Committee Chairman Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) to craft the language in the bill.
Bennet’s other provisions in the FDA reauthorization bill include:
- The drug safety component of the bill to secure the supply chain builds upon Bennet’s Drug Safety and Accountability Act, which he introduced last Congress in response to the record-high number of drug recalls. With 80 percent of the active pharmaceutical ingredients in our U.S. drug supply being manufactured abroad, this bill enhances the ability of the FDA and increases oversight of the pharmaceutical industry to ensure U.S. prescription and over-the-counter drugs are both safe and effective – regardless of where they are made.
- The drug approval and patient access component of the bill includes a bipartisan bill led by Bennet, along with Senators Orrin Hatch (R-UT) and Richard Burr (R-NC), to expedite U.S. Food and Drug Administration (FDA) approval and provide more flexibility for breakthrough drugs or treatments that show dramatic responses early in development, while still ensuring drug safety and efficacy. For patients, this proposal also would allow FDA the ability to move toward more innovative clinical trials, such as minimizing the number of patients enrolled in trials with a placebo and shortening the duration of trials when scientificallyappropriate.
- The medical device component of the bill includes Bennet-backed measures to improve innovation and safety in medical devices, including Bennet’s bill to reduce regulatory burdens that unnecessarily delay new medical devices from reaching the market, such as delays in the 510(k) process, as well as language from Bennet’s bill to give the Food and Drug Administration the tools it needs to improve oversight and tracking of medical devices after they are approved.
- The medical mobile apps component includes a modified version of an amendment Bennet offered and subsequently withdrew during the HELP Committee’s markup of the bill. The language calls on FDA to carefully review regulations and to clarify rules for developers in the rapidly growing field of medical apps for mobile devices.
- Bennet was part of the bipartisan working group that drafted the drug shortage component of the bill. This piece would enhance the ability of the FDA to address and avoid drug shortages. The plan calls for enhanced notification of potential drug shortages or disruptions and gives FDA authority to expedite reviews of drugs in short supply to mitigate the effects of a shortage.
- The new antibiotic development component of the bill includes the GAIN Act, a bipartisan bill cosponsored by Bennet to spur development of new drugs to treat increasing cases of bacterial infections resistant to conventional antibiotics, which are particularly prevalent among military personnel returning from overseas. This provision provides incentives to increase the commercial value of innovative antibiotic drugs and streamlines the regulatory process so that pioneering infectious disease products can reach patients.
Bennet was also part of the bipartisan working group that drafted the pediatric component of the bill, which would help ensure drugs and medical devices are specifically tested, labeled, and proven to be safe and effective for children. It also ensures children are prioritized in the drug development process and that drug labels provide clear, detailed information about the proper use and dosage of medications for children.