Food And Drug Administration

The Food and Drug Administration has been a cornerstone in the fight to improve Americans’ health. Due to the vital nature of the FDA’s public health oversight, PhRMA stands behind an empowered agency that is adequately resourced through enhanced congressional appropriations to conduct its crucial mission.

Bolstering the scientific and developmental environment that promotes medical progress is a national priority. Over the last half-century, new medicines and medical technologies have revolutionized health care and helped millions of patients live longer, healthier lives. America is on the brink of a new era of biopharmaceuticals and personalized medicine.

The optimal regulatory environment needed to transform this promise into reality has its foundation in a few key principles: science-based decision-making, innovation, collaboration, transparency and accountability.

PhRMA looks forward to working with FDA leadership in helping to ensure that patients have access to a steady supply of new and innovative medicines to address unmet medical needs. PhRMA wholeheartedly agrees with FDA Commissioner Margaret Hamburg’s focus on science-driven decision-making at the agency and applauds the FDA’s clear focus on helping to ensure the safety and effectiveness of medicines in the U.S. supply chain. And PhRMA is eager to continue working with the FDA, as a constructive partner, to help advocate for robust congressional appropriations to assist the agency in strengthening its scientific base.

By charging user fees during the era of the Prescription Drug User Fee Act, the FDA has gained the resources and additional staffing it needs to review new medicines more efficiently while also maintaining its stringent safety and efficacy standards. Within the 2012 reauthorization bill, it is essential to return to the original mission of PDUFA: New drug reviews must be accomplished in a way that is efficient, predictable and well-coordinated within FDA, helping to ensure that patients have timely access to safe and effective medicines.

In the interim, the FDA will continue the important task of implementing drug-safety authorities, modernizing FDA methods for evaluating safety and efficacy throughout a product’s life cycle, and implementing the new biosimilar approval pathway and finalizing an important project aimed at enhancing its transparency.

News*

Co-Development of Two or More Investigational Drugs for Use in Combination 
PhRMA appreciates the FDA's efforts in developing guidance for industry concerning the co-development of two or more novel, not previously marketed drugs to be used in combination to treat a disease or condition.

Principles For Biosimilars Approval
Marie A. Vodicka, PhRMA's associate vice president for scientific and regulatory affairs, testified at the FDA's public hearing on implementing the new biosimilars approval pathway that the agency should be guided three principles.

National Take Back Day
PhRMA stands behind National Take Back Day, an effort spearheaded by the Drug Enforcement Administration to let patients drop off expired, unused and unwanted prescription drugs at designated sites nationwide.

Enhanced Transparency In Clinical Research
PhRMA and its member companies have a longstanding commitment to the ethical conduct of clinical trials and to increasing transparency by reporting more information about clinical trials.

*These are select PhRMA comments and other submissions to the FDA. This page is not intended to provide a complete listing of all PhRMA submissions.