Food and Drug Administration

For over 50 years, PhRMA and the FDA have worked together to ensure the safety and integrity of medicines

For more than 50 years, PhRMA and its member companies have partnered with the Food and Drug Administration (FDA) to ensure the safety and integrity of medicines before and after they are approved for patient use.

In the pharmaceutical industry, drug safety is paramount. The FDA’s role in reviewing new medicines is crucial as is its work in restricting counterfeit drugs and educating the public about prescription drug abuse.

Due to the vital nature of the FDA’s public health oversight, we stand behind an empowered agency that is adequately resourced through enhanced congressional appropriations.

From Past to Present

Over the last half century, new medicines, medical technologies, and increased pharmaceutical research have revolutionized health care and helped millions of people live longer, healthier lives. And the pace of innovation has steadily increased.

America is on the brink of a new era of biopharmaceuticals and personalized medicine.  The regulatory environment needed to transform this promise into reality has its foundation in a few key principles:

  • science-based decision-making
  • innovation
  • collaboration
  • transparency
  • accountability

PhRMA applauds FDA Commissioner Margaret Hamburg’s focus on science-driven decision-making and clear focus on helping to ensure the safety and effectiveness of medicines in the U.S. supply chain.

We continue working to help advocate for robust congressional appropriations to assist the Agency in strengthening its scientific base.

The recent authorization of Prescription Drug User Fee Act V (PDUFA V) means new drug reviews will be performed in a way that is more efficient, predictable and well-coordinated within the FDA, increasing timely patient access to safe and effective medicines.

About 97 percent of the medicines approved by the FDA over the past two decades are still on the market and considered safe. While this is a solid collective track record, America’s biopharmaceutical companies continuously strive to make a good system even better, and we look forward to working with FDA leadership in helping patients continue to have access to a steady supply of new and innovative medicines in the future.

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