This editorial by Dana McDougall was published in The Waterloo Cedar Falls Courier on August 26, 2019. Mr. McDougall, Pharm.D., BCPS, is a pharmacist with the Covenant Cancer Treatment Center in Waterloo, Iowa.
Safety of medicines at risk in Senate bill
As a pharmacist at a cancer treatment center here in Waterloo, I am honored to serve generations of Iowans and to be trusted with the responsibility for their medication therapy every single day.
The health and safety of my neighbors, family, and community is always my top priority. A lot goes into ensuring the safety of medicines in the U.S.; this enables us to have one of the safest supplies of prescription drugs in the world. The Food and Drug Administration only approves medicines that have been rigorously tested and shown to be effective in treating or preventing disease, and brave men and women in the Customs and Border Patrol keep counterfeit medicines from coming into our country. All of this is underpinned by quality and safety standards that have been around for over a century.
However, the U.S. Senate is considering legislation that would remove long-standing requirements for drug companies to comply with quality and safety standards for some prescription medications, known as biologic drugs.
Unlike traditional medicines like aspirin, biologics are treatments made from living organisms. Thanks to innovation in biotechnology, a diverse and growing list of biologics, like Humira, have been approved in the U.S. to treat heart disease, arthritis, cancer, and other deadly diseases. These medicines are extremely effective, and more and more biologics will benefit patients every day. Others, like insulin, have been around for decades, but are continuously evolving to become more effective, as are the quality standards that ensure their safety and effectiveness.
If enacted, this bill could directly harm the patients I serve. Iowans must be confident in the quality of the medicines they take, relying on everything from strength to purity to appropriate dosage. Anything that could harm that trust is a bad idea and should be rejected resoundingly. This is especially critical as our medicine supply is increasingly dependent on the global supply chain. Many medicines, or their ingredients, are foreign sourced, and the presence of public quality standards could not be more important.
National pharmacist associations recently signed a letter asking Senate leaders to oppose this provision, noting it will not help lower drug costs and may instead compromise the health and safety of patients. The letter stated that more than 80 percent of ingredients in the medicines we take now come from other countries, many of them in the developing world. In today’s globalized medication supply, taking a belt-and-suspenders approach to safety is imperative.
The current quality medicine standards are available to anyone, bolstering public trust in the medicines we take. Public standards establish the parameters by which medicines can be evaluated regardless of the manufacturer or the source of ingredients. Unlike private standards developed by for-profit corporations, public standards allow anyone to test the quality of a drug anywhere along its supply chain. As manufacturing processes grow more complex and foreign suppliers play a bigger role in what our medicines are actually made of, transparent quality standards have never been more important.
The American Cancer Society opposes this provision, as does the American Association for Retired Persons. And so do I.
For more than 100 years, these standards have helped ensure medicines used in the U.S. are safe and effective. There’s no good reason to repeal them. I hope we can count on Senator Grassley and Senator Ernst to fight back against this misguided legislation.