Energy and Commerce
U.S. House of Representatives
As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our strong support for several provisions in The Food and Drug Amendments Act (H.R. 7667), and our concerns about other provisions that could be improved. The coalition was founded more than two decades ago and is an informal group of nonprofit organizations representing millions of patients, consumers, health professionals, and public health advocates (see www.patientsandconsumers.org).
There are numerous important provisions in the FDA Act, but in this letter we will focus on two major issues: accelerated approval and contrast imaging agents.
- Accelerated approval needs to be strengthened, because patients are being seriously harmed (medically and financially) by drugs that are not proven safe or effective and yet stay on the market for many years—even after it is shown that their harms outweigh their benefits.
- We strongly support Section 804, which requires the confirmatory study for a drug approved under the accelerated approval pathway to be started beforethe approval is in effect. The definition of “started” should be clearly defined to include clinicians already recruited and patients being enrolled. Otherwise, it could be years before patients are enrolled and even more years before the study is completed.
- We strongly urge that the “may” language in Section 804 be replaced by “shall”, to ensure that FDA’s requirements for confirmatory studies are enforced and ineffective drugs do not remain on the market for longer than necessary.
- We strongly urge that you insert the 5-year automatic expiration of accelerated approval that was included in HR 6963 but excluded in HR 7667.
- While we recognize the value of real-world evidence (RWE), there would not be sufficient RWE data for a confirmatory study conducted in a timely manner. That’s because it would take many years for a new drug to be used by a sufficient number of patients who are representative of those with the same medical condition. For that reason, we strongly urge you to delete the RWE provision pertaining to accelerated approval.
- There has been misleading media coverage pertaining to Section 803 regarding contrast imaging products, as it related to the court decision regarding Genus Medical Technologies v FDA. We want to clarify that Section 803 would notoverturn the court, but rather keep contrast imaging products as drugs, as they have been for 25 years. This is necessary to ensure that physicians and patients have the same level of information about new contrast imaging agents as they do for those currently on the market, and that FDA continues to vet these products to ensure that they are safe and effective. For example, if the current regulatory requirements had not been in place, FDA would not have determined the risks of gadolinium contrast agent for people with damaged livers; fortunately, the FDA’s warnings and policies on that issue have saved many lives.
Thank you for your work on this important legislation. If you have any questions or need more information, please contact Sophia Phillips at email@example.com.
American Medical Students Association (University of Wisconsin chapter)
Breast Cancer Action
Breast Implant Safety Alliance
Doctors for America
Jacobs Institute of Women’s Health
Medical Device Problems
Mothers Against Medical Error
National Center for Health Research
National Women’s Health Network
Our Bodies Ourselves
Patient Safety Action Network
The Society for Patient Centered Orthopedics
USA Patient Network
Washington Advocates for Patient Safety