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The Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act is a needed piece of legislation to enhance patient safety by increasing oversight of compounding pharmacies, and congressional committees should mark up the bill as soon as possible, the NAM said recently.

What’s going on: “The SAFE Drugs Act is an important step toward protecting patients from underregulated compounding pharmacies’ production of potentially unsafe drugs that have not been approved by the Food and Drug Administration,” the NAM told leadership of the House Energy and Commerce and Senate Health, Education, Labor and Pensions Committees last week.

• The legislation, sponsored by Reps. Rudy Yakym (R-IN) and Andre Carson (D-IN) and Sens. Jim Banks (R-IN) and Martin Heinrich (D-NM), “would crack down on compounding issues by giving the FDA more authority over … facilities [where compound drugs are made]. The bill would require compounding manufacturers to report activity to the FDA, mandate inspections and set a limit on how many ‘copies’ of a drug can be produced each month” ( Bloomberg).
• The NAM has long urged oversight of non-FDA-approved compounded medications, citing safety and health concerns.

Why it’s critical: “[C]ompounded drugs may be unsafe due to unsterile manufacturing conditions, may have incorrect potency or dosing, may contain active pharmaceutical ingredients (APIs) from unregulated and uninspected foreign facilities and may contain APIs that are research- or animal-grade instead of human-grade,” the NAM told congressional leadership.

• The NAM cited GLP-1 drugs, used widely to treat diabetes and obesity, as an example: Over 22,000 vials and syringes have been recalled due to safety concerns, and the FDA has received thousands of reports of adverse events associated with compounded GLP-1s. Patient symptoms have ranged from vomiting and sepsis to liver failure and even death.
• With GLP-1 drug supplies no longer in drastically short supply, the FDA last week issued a clarification on its website regarding its policy for GLP-1 ​compounders.

What Congress should do: “Given the threat to patient safety posed by mass compounders, manufacturers request that your respective committees hold mark-ups on the SAFE Drugs Act,” NAM Vice President of Domestic Policy Jake Kuhns and NAM Director of Health Care Policy Jess Wysocky concluded, and, as always, offered to be a resource as the legislation moves through the deliberative process.