WASHINGTON, D.C. – This week,Senator Jim Banks (R-Ind.) introduced the Safeguarding Americans from Fraudulent and Experimental (SAFE) Drugs Act. The bill would strengthen existing guardrails and close loopholes in the Food, Drug, and Cosmetic Act to stop unapproved compounders from mass-producing risky drugs in unregulated and uninspected facilities. Senator Martin Heinrich (D-N.M.) cosponsored the bill.
Alliance for Safe Online Pharmacies: “The Alliance for Safe Online Pharmacies (ASOP Global) applauds introduction of the SAFE Drugs Act in the Senate and thanks lawmakers for prioritizing patient safety in the rapidly evolving online drug marketplace,” said ASOP Global Board Member Leigh Verbois. “By closing dangerous regulatory loopholes and strengthening FDA oversight, this bipartisan legislation takes an important step toward protecting patients from unsafe, unapproved, and fraudulent medicines, no matter where or how they are sold.”
National Association of Manufacturers Managing Vice President for Policy Charles Crain: “Manufacturers appreciate the efforts of Sen. Banks and Sen. Heinrich to protect the safety and reliability of the U.S. drug supply from unsafe medication caused by unsound compounding practices through introduction of the SAFE Drugs Act. Strengthening guardrails, increasing oversight, and appropriately resourcing FDA to inspect outsourcing facilities will ensure patient safety comes first for manufacturing workers, their families, and all Americans.”
Partnership for Safe Medicines Executive Director Shabbir Safdar: “The Partnership for Safe Medicines has consistently warned about the dangers of mass-produced compounded injectable medications and the use of unregulated foreign ingredients in these products. The SAFE Drugs Act aims to restrict illegal mass compounding operations while preserving the essential role of compounding in serving patients whose medical needs can’t be met with a commercial product. Through its reporting and inspection provisions, the SAFE Drugs Act will bring much needed transparency to the mass marketing of compounded drugs and strengthen compliance at outsourcing facilities. Congress must act swiftly to pass this bill to establish these vital safeguards to patient safety.”
American Diabetes Association Vice President Catherine Ferguson: “While compounded medications play a critical role in our health care system, concerns have emerged regarding the widespread availability and promotion of non-FDA approved compounded GLP-1 and dual GIP/GLP-1 RA medication classes to treat obesity directly to patients. The American Diabetes Association (ADA) issued a statement recommending against the usage of compounded GLP and dual GIP/GLP-1 RA medications due to uncertainty about their content, safety, quality and effectiveness. The ADA is committed to ensuring patients have access to safe and effective FDA approved medications to treat their diabetes and obesity. Additional FDA oversight is needed regarding these compounding practices for these medication classes and entities manufacturing them to protect patients with diabetes and obesity.”
Read the full text here.
Key Provisions of the Safeguarding Americans from Fraudulent and Experimental Drugs (SAFE) Act:
- Clarify that compounded drugs with the same active ingredient as an approved medicine are considered “essentially a copy” unless clinically different for a specific patient.
- Set a clear monthly limit on how many “essential copies” a 503A compounder may produce to ensure consistency and reduce litigation.
- Define “commercially available drug product” to prevent 503A compounders from mass-producing approved medicines.
- Require 503A compounders to report to the FDA any out-of-state shipments of compounded drugs containing approved active ingredients above a prescription threshold.
- Require FDA inspections of outsourcing facilities before large-scale compounding begins, with follow-up inspections every two years.
- Increase the base outsourcing facility user fee to a level set by HHS to support timely and regular inspections.
Background:
Americans rely on the Food and Drug Administration (FDA) to ensure that prescription drugs are safe and effective. Typically, prescription drugs cannot be marketed or sold without FDA approval. Compounding is a narrow exception to that rule and is allowed only when approved medicines cannot meet a patient’s unique medical needs or in times of extreme drug shortages. However, over the past several years, some compounders began abusing these narrow exceptions by mass-producing and marketing unapproved drugs. These unapproved compounded drugs are not produced in FDA-inspected facilities and often use active pharmaceutical ingredients (API) that are made in foreign, unregistered, and unregulated facilities, increasing the safety risk.
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