This editorial by Ron Fitzwater was published in The Missouri Times on July 27, 2022. Mr. Fitzwater is the Chief Executive Officer of the Missouri Pharmacy Association.
Reauthorize PDUFA – Without Dangerous New Schemes
The Prescription Drug User Fee Act (PDUFA) is up for reauthorization this year, and like many other groups and associations, the Missouri Pharmacy Association (MPA) is very interested in the prompt passage of this legislation.
Some members of Congress are pushing legislative amendments and tacking on extraneous measures or pet projects which can delay or derail the reauthorization of PDUFA.
First passed in 2003, PDUFA establishes how new drugs are approved by the Food and Drug Administration. It also provides the fees paid by the manufacturers to hire the scientists, experts, and inspectors at FDA who ensure the drugs are safe and effective. Inspectors protect the drugs supply at every step along the supply chain from manufacture to our drug store shelves.
PDUFA has been reauthorized by Presidents and Congresses of both parties on a bipartisan basis ever since. We don’t need to radically change something that has worked well and has kept America’s drug supply safe. PDUFA’s prompt reauthorization is important to pharmacists across Missouri and the whole country because it means a continued flow of safe and effective drugs to American consumers. If it is allowed to expire, some parts of the FDA will experience shutdowns and layoffs, which will make it difficult for FDA to ensure America’s drug supply chain remains the safest in the world.
One proposed amendment which could delay, or derail prompt passage, would allow importation of drugs from other countries which have not been inspected or approved by the FDA. Because the FDA ensures strict oversight of purity and effectiveness of the drugs in our supply chain, this proposal is dangerous. Everyday customs officials are finding counterfeit drugs which are laced with dangerous ingredients like fentanyl, mercury, lead, or other toxins.
Even drugs which appear to come from modern western countries like Canada, may have originated in third world countries without proper oversight and inspection. When they arrive in American, they do not have the seal of approval from either Canadian or US health officials.
While these importation schemes are proposed to save American’s money, the fact is that 90% of all drugs prescribed in America are for generic drugs and generic drug prices in America are already lower than in countries like Canada.
The Missouri Pharmacy Association is a committed group of professional pharmacists with high standards and goals. The safety of our patients is always a priority. Because MPA has a rich history of involvement in pharmacy issues on state and national levels, I am writing to raise our voices in opposition to drug importation and other schemes which will slow down approval of PDUFA. Drug importation will not lower drug prices and it will put our customers in danger.
Our patients need access to new life-saving medications. Delay in passing PDUFA will stall the process of approving those drugs. Tacking on dangerous schemes like drug importation will endanger patient’s health, and in some cases their very lives. Congress should NOT put the safety of the American drug supply at risk with schemes which won’t deliver consumer savings but could endanger the citizens we as pharmacists serve. Pass a clean PDUFA now.