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This past week the new Food and Drug Administration (FDA) commissioners outlined a turn-around plan. The FDA, an agency apart of the Department of Health and Human Services (DHHS) is responsible for “protecting the public health”, as stated by the Supreme Court. This entails the oversight of over $2 trillion in medical products, foods, and other consumer goods.
FDA commissioners Margaret Hamburg, MD and Joshua Sharfstein, MD published a persepctive online in the New England Journal Medicine concerning the strategy the FDA will take to become a leading, trustworthy agency for the public. As such they stated it is the FDA’s job to support access to safe and nutritious food and a safe and effective drug supply to ultimately promote health, prevent illness, and prolong life. The ultimate success of the agency will not be depedent upon the number of facilities inspected or drugs approved.
The commissioners pointed out that collaboration with other federal agencies and external partners is necessary to ensure successful outcome of the advancement of science and any threats to the safety of the food or drug supply. Moving forward the FDA will work closely with the Centers for Disease Control and Prevention (CDC) to identify areas of action, such as outbreaks of food-borne illness. The FDA will partner with the National Institutes of Health (NIH), academic medical centers, and universities to find solutions to medical problems. In addition, the FDA proposed they will work with the Centers for Medicare and Medicaid Services to explore ways to shorten the time from approval to reimbursement. Other partnerships will need to exist including one with the Department of Agriculture to establish a modern and up-to-date food safety system to prevent contamination and outbreaks from food-borne illness. With regard to nutrition, the FDA will support efforts to educate the public about nutrition and promote healthy foods.
In the U.S., there are over 200,000 companies selling food, cosmetics and medical products. This indeed presents a challenge to manage. The FDA has propsed to access imported products for any potential negative impact. Safety standards must be put in place where none currently exist, which include assessing the country of origin, the importer, the importing country, and the final company in the supply chain.
Minimizing risk through education, regulation and enforcement will be part of the FDA’s ongoing role. Risks and benefits will need to be clearly communicated to the public. However for this to be effective, the public and congressional leaders will have to begin trusting the FDA as a credible source. Establishing the FDA as a public health agency will require the public interest being served and not be self-serving or compromising. Transparency will be key in order to begin building that trust with the public once again. The commissioners stated, “Whenever possible, the FDA should provide the data on which it bases its regulatory decisions and other guidance and explain its decision-making processes to the public.”
In closing it was noted “Succeeding will require respecting the tradition of the FDA and its mission of public health.” We will have to wait and see if these intended plans will make an impact on the safety and well-being of the American public. For now, the FDA has come to terms with their past mistakes and has willingly began to open their doors to create partnerships and collaborations which will better serve the public.
