Dear FDA Matters readers: FDA Matters’ newest feature puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community. Two prior Spotlight columns are here and here. More will follow. If you are aware of a cause or an organization that could benefit from a spotlight column, please reach out to me. Thanks. Steven
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Last Fall, I wrote an FDA Matters column titled “FDA is the Department of Homeland Security for Food and Drugs” (here). It described how FDA is responsible for oversight of more than $3.9 trillion worth of food, medical products, and tobacco consumption. I observed that “even long-time FDA-watchers don’t understand the strength of the motivation or the size of the profit that is derived from cutting corners on product quality or otherwise evading FDA regulation.”
Today’s guest is Shabbir Safdar, Executive Director of the Partnership for Safe Medicines (https://www.safemedicines.org/). PSM is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. Given the size of the US pharmaceutical market and the complexity of the supply chain, the threat of harm from counterfeit products is substantial even though only a small percentage of drugs are compromised.
Steven: When and why was PSM created?
Shabbir: The Partnership for Safe Medicines is a public health group established in 2003 to research and share information about the dangers of counterfeit medicines. Our members and funders are other non-profit organizations dedicated to protecting consumers from these harmful drugs. Our mission is to educate policymakers on the need to protect the U.S. drug supply and to inform the public about the risks of using medicines from unregulated sources.
It is an enormous and ongoing task to track problems in the drug supply chain, but we know the information we collect and distribute saves lives and reduces unnecessary harm to American patients and consumers.
Steven: What is PSM’s policy agenda?
Shabbir: Our core policy agenda has six parts: 1/ raising patient awareness, 2/ enhancing pharmaceutical border security, 3/ ensuring safety for the supply chain, 4/ opposing policies that endanger the supply chain, 5/ ending the fake pill/fentanyl trade, and 6/ promoting regulation of online venues where illegal medicines may be sold.
Steven: On a day-to-day basis, what are some of the issues PSM tracks?
Shabbir: The range of issues is remarkably large. In recent weeks, our newsletter (sign up here) covered use of low-cost vials and questionable shipping methods at a new online pharmacy; a Washington Post news story on a patient harmed from compounding a GLP-1 with B-12; and our letter supporting HR H.R. 2715, legislation that would authorize the FDA to destroy products posing public health risks. In the latter case, it reflects the reality that criminals are just taking those dangerous shipments back and “re-shipping” them through a different port to sneak them into the U.S.
We recently released a report on our surveillance of the pharmacy-to-pharmacy marketplaces. These markets can help pharmacists to manage inventory, but they also create opportunities for bad actors to introduce counterfeit or diverted medicines into the supply chain. Our latest Suspicious Sales Surveillance Report (here) highlights alarming findings from some products priced “too good to be true.” These deals often signal risk, not savings.
Steven: Have you been involved in issues surrounding GLP-1 compounding?
Shabbir: In recent years, demand for GLP-1 weight loss and diabetes medicines has transformed compounding from an industry designed to serve the specific needs of individual patients and address drug shortages…into an underregulated arm of U.S. drug manufacturing. A shift in the volume of production has led to an increase in unsafe compounding, often by unlicensed practitioners at uninspected sites, using ingredients sourced from overseas facilities not registered with the FDA. ]
While this has started as a specific issue with GLP-1, the expansion of unregulated compounding is now a precedent that is likely to spread to other drug categories, most immediately peptides.
Steven: What other threats do you see in the US drug supply system?
Shabbir: We are monitoring the rise of alternative funding programs that facilitate drug importation for self-funded health insurance plans. These programs promise employers significant savings by securing cheaper prescription medicines for their employees, but they often achieve this with drugs that have been illegally shipped from overseas. By side-stepping the U.S. regulatory system, this greatly increases the risk of encountering counterfeit or substandard prescriptions. Some U.S. patients are paying substantial health care premiums and yet they are not getting FDA-approved medicines.
Steven: Does PSM work with FDA and other government agencies?
Shabbir: PSM supports the work of state and federal government agencies related to medication safety, but we don’t have a formal relationship with any government or law enforcement agency. We do, however, continually communicate with law enforcement groups, boards of pharmacy, and pharmacy associations across the country to keep up with and share information about new developments in counterfeit drug trafficking. Our Freight Reports are a great example of this; they are currently being shared with security teams at the federal, state, and pharmaceutical manufacturer levels.
We believe the FDA plays a key role for all American patients in ensuring the safety and efficacy of medicines and in the safety of the supply chain. We routinely follow FDA’s regulatory actions and publicize prosecutions brought by the FDA’s Office of Criminal Investigations in order to make sure people understand the importance of protecting the supply chain. We also work hard to advocate for the FDA in Congress, especially by highlighting the need for additional authorities.
Steven: If interested in PSM’s mission and goals, how can individuals and groups get involved?
Shabbir: PSM is always interested in information about unsafe medicines and systemic issues that threaten the safety of medicines. Individuals can sign up for our weekly email at safemedicines.org to stay up to date on the news.
Contact us at editors@safemedicines.org if: 1/ you have a tip for us, 2/ you or your group wants more information about counterfeit drugs, or 3/ your organization has patient safety in its mission and would like to work with us.
