Congress Should Not Compromise Prescription Drug Safety
America is getting older. More than 10,000 Americans turn 65 every day. This demographic shift highlights the need for affordable medicines that will help older Americans stay healthy, active, and productive lives.
Biologics, new treatments made from living organisms, offer relief to seniors with chronic conditions such as arthritis. Officials from the Centers for Disease Control and Prevention (CDC) estimate the number of adults in the U.S. living with arthritis to be about 54 million. The number may be even larger, with younger patients not seeking treatment.
As promising as biologics are, they are also extremely expensive. For example, under Medicare Part D, the median out-of-pocket cost to a patient using a biologic to treat rheumatoid arthritis is more than $5,000 per year. Patients are already stressed about how to pay for the drugs upon which they depend; quality and safety should be a given, not an additional question mark. If legislation currently being considered in Washington, DC is passed by Congress, the public quality and safety standards biologic drugs are required to adhere to could be repealed. We all should be concerned.
Under the current system, once a traditional small-molecule drug or biologic is approved for sale by the Food and Drug Administration (FDA), an independent, nongovernmental organization called the U.S. Pharmacopeia (USP) establishes standards for safety, quality, dosage, and effectiveness for that treatment. The USP has filled this role effectively for decades.
Committees of experts, including medical and scientific researchers, former regulators, and pharmacists all contribute to the development of these public, transparent standards. These standards are used in the United States and other countries to reassure doctors that their patients are taking safe medicines that work as promised. Customs agents even use them to prevent counterfeit or substandard drugs from entering the country and causing harm to patients already suffering from painful and deadly diseases.
The Senate is considering legislation this summer that would exempt biologics from USP standards. There is simply no reason to change the current system, which ensures safety and efficacy for patients and physicians while encouraging competition, as well.
Producers of biosimilars, which make medically equivalent versions of biologics at lower cost, utilize USP standards to benchmark their own products against biologic drugs. Competition between biologics and biosimilars could save consumers and taxpayers billions of dollars. In Europe, which has a similar process to the USP standards, patients have benefitted from billions in cost savings over a decade.
Repealing safety and efficacy compliance requirements, not to mention transparency, is risky.
The Alliance for Retired Americans, patient groups like the Arthritis Foundation and the American Cancer Society, and the AARP all oppose this legislation. The Arthritis Foundation said it “believes public standards comprise a key element of what has made the United States a leader in assuring quality, purity, and strength of medications.” We could not agree more.
Transparency breeds trust; secrecy and opacity breeds mistrust. Placing compliance solely into the hands of the FDA and pharmaceutical corporations with no public input or oversight could undermine the trust between doctors, patients, and pharmacists, all of whom rely on the existing standards.
Time and time again we have been reminded that industry self-reporting doesn’t work. Regulatory agencies are already stretched too thin to keep up with their oversight and enforcement roles. The current U.S. system does work. The USP standard add an additional safety net in developing countries like China and India, which supply many of the ingredients in the drugs we take every day.
Congress should stay focused on the most urgent health care crisis of our time — prescription drug affordability — and reject all legislation that could jeopardize the safety of the medicines we put into our bodies every day.
Richard Fiesta is the Executive Director of the Alliance for Retired Americans, a grassroots organization with 4.4 million members nationwide that works to protect the health and welfare of all retirees.
