For years, the Obesity Action Coalition (OAC) has advocated for common-sense patient safety reforms to strengthen oversight of compounded medications. OAC has consistently urged policymakers to improve transparency, strengthen adverse event reporting, enhance regulatory oversight and ensure people understand exactly what medication they are receiving.

At the same time, OAC has been clear about why many people turn to compounded GLP-1 medications. Too many cannot access FDA-approved obesity treatments because of insurance exclusions, restrictive coverage policies and unaffordable costs. When science-based treatment is out of reach, it is not surprising that people seek alternatives.

The changes made to the Safeguarding Americans from Fraudulent and Experimental Drugs (SAFE Drugs) Act through the Senate Health, Education, Labor and Pensions (HELP) Committee’s manager’s amendment reflect several of OAC’s long-standing priorities. OAC believes the amended legislation takes important steps to improve patient safety through greater transparency, accountability and coordination among federal and state regulators.

Here’s What the Amended SAFE Drugs Act Would Do

The manager’s amendment includes several patient-centered improvements designed to strengthen transparency and oversight of compounded medications. Specifically, it would:

  • Require clearer labeling so patients know when a medication is compounded and not FDA-approved.
  • Expand adverse event reporting by requiring compounders to report serious safety events to FDA and state regulators.
  • Improve oversight of interstate compounding by requiring compounders that distribute medications across state lines to report information about their operations.
  • Strengthen coordination between FDA and states to improve communication about safety concerns involving compounded medications.
  • Preserve states’ authority to adopt additional patient safety and reporting requirements beyond the federal standard.

These are practical, common-sense reforms that align with OAC’s long-standing advocacy for greater transparency, accountability and patient protections.

A Long-Standing Commitment to Patient Safety and Access

OAC’s support for these provisions is not new.

Pharmacy compounding serves an important and legitimate role in healthcare when performed in accordance with federal and state laws. However, too many people have lacked clear information about whether the medication they receive is FDA-approved or compounded, where its ingredients come from, how it was prepared or what to do if something goes wrong.

OAC has also emphasized that the growth in compounded GLP-1 use cannot be separated from the broader failure to provide affordable access to FDA-approved obesity treatments. People are not turning to compounded medications because they prefer less oversight. They are often doing so because the treatment recommended by their healthcare professional is inaccessible or unaffordable.

Strengthening safeguards for compounded medications and expanding access to FDA-approved treatments must go hand in hand.

What’s Next?

The Senate HELP Committee’s consideration of the SAFE Drugs Act demonstrates why the legislative process matters. Committee review, stakeholder input and thoughtful amendments can strengthen legislation and ensure it better reflects the needs of people and the realities of healthcare.

The manager’s amendment is a good example of that process in action. It incorporates several practical, patient-centered improvements that OAC and other stakeholders have advocated for, resulting in a stronger bill than the version originally introduced.

While OAC is encouraged by these changes, it is important to recognize the bill’s legislative outlook. With limited time remaining in the 119th Congress and many competing legislative priorities, it is unlikely the SAFE Drugs Act will receive a vote on the Senate floor or be taken up by the House of Representatives before the end of this Congress.

Even so, the progress made through the committee process is meaningful. The manager’s amendment helps shape the ongoing conversation around compounded medications and establishes a foundation should Congress revisit this issue in future legislation. OAC will continue working with policymakers to advance practical, person-centered policies that improve both patient safety and access to science-based obesity care.