Hi “Senate Staff First Name,”
The House Appropriations bill for FDA includes riders that will harm your constituents by reducing the safety and effectiveness of drugs and devices. These provisions include dangerous sections of the House’s 21st Century Cures Act that the Senate HELP Committee rejected.
This graphic says it all: Fast drugs can be more dangerous than fast food. FDA reviews need to protect patients and consumers from unsafe and ineffective medical products. (The specific provisions in the House Approps bill are below the graphic.)
We are asking that your boss protect patients and consumers by opposing any riders to the Senate Approps bill that would weaken FDA’s standards for approving drugs and medical devices. Those standards are needed to protect patients and keep FDA the gold standard.
Please call or email me if you have any questions,
Government Relations Manager
Please reject the following from the House Appropriations bill for Agriculture and the FDA
1. Subtitle A–Patient-Focused Drug Development
(HR 6, Sec. 2001) This bill amends the Federal Food, Drug, and Cosmetic Act to require the FDA to establish processes under which patient experience data may be considered in the risk-benefit assessment of a new drug. The FDA already considers patients’ experiences as part of the approval process. But this language would pressure the FDA to use anecdotal evidence to replace scientific evidence.
2. Subtitle D–Modern Trial Design and Evidence Development
(HR 6, Sec. 2061) The FDA must issue guidance that addresses using “alternative” statistical methods in clinical trials and in the development and review of drugs.
3. (HR 6, Sec. 2062) To support approval of a drug for a new indication, the FDA must evaluate the use of evidence from clinical experience (in place of evidence from clinical trials) and establish a streamlined data review program.
4. Language to delay FDA’s important rule enabling them to regulate lab developed tests.
5. Title II Subtitle L from 21st Cures (“priority review of devices” – lowering standards).
6. A rider in the report that would require FDA to suspend finalizing their excellent rule requiring that adverse reactions be up to date on labels for generic dr