FDA should remain the authority on the safety and effectiveness of medicines

Recent district court rulings set an alarming precedent that calls into question the authority of the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of new medicines.

The FDA is the gold standard for determining whether a medicine is safe and effective. The FDA evaluates volumes of scientific data prior to approval and continues to assess the risks and benefits long after a medicine is approved. These rigorous evaluations give American patients the confidence that what they’re picking up at the pharmacy is safe and effective.

PhRMA has serious concerns with any court substituting its opinion for the FDA’s expert approval decision-making. Patients and their doctors rely on the FDA to serve as an expert and trusted arbiter of what medicines are safe for use so they can make the most informed health care decisions. Moreover, undermining the FDA’s longstanding authority given to them by Congress to approve drugs would have a chilling effect on the research and development ecosystem. Biopharmaceutical researchers and scientists need certainty that FDA approvals will be upheld so they can make the long-term investments required to develop new medicines and ultimately get them approved for use by patients.

At a time when medical innovation has never been more promising, it is vital we have a legal and policy environment that fosters the development of new treatments and cures and protects patients’ access to the medicines they need. We will continue to explore all policy and legal options to ensure the FDA’s approval authority is protected.