Recently, Congressman Morgan Griffith (R-VA) along with Congressman Henry Cuellar (D-TX), introduced HR 2871, a bill to further ensure access to needed medications, while maintaining the safety of compounded drugs by clarifying the regulatory authority of the US Food and Drug Administration (FDA).
The bipartisan Drug Quality and Security Act (DQSA) was signed into law in 2013 with Congressman Griffith’s support and some of his language. But FDA’s interpretation of parts of the law threatens the ability of pharmacists and doctors to best serve their patients and hinders those patients’ access to needed medications.
Congressman Griffith said, “This bill continues my efforts to reach a balance, allowing compounding pharmacists to provide high quality and safe drugs, while maintaining proper oversight.”
“FDA has ignored the clear intent of Congress in their implementation of the law subsequent to the passage of the DQSA. FDA needs to go through the formal rule-making process, which would require notice and a comment period, rather than continuing to issue guidance without stakeholder input.”
“It is my hope that this legislation will bring clarification as to what the FDA should be doing within their regulatory authority to ensure patient safety, while leaving the regulation of the traditional practice of pharmacy to the states, as it has always been.”
“Specifically, this bill protects pharmacies engaged in office-use compounding. Doctors do not generally compound drugs and few of them are trained to do so. In one example, these regulations could prevent a doctor’s office from having drugs on hand that could save a patient’s vision in an eye emergency. If the doctor doesn’t have the drugs on hand, there is no guarantee a pharmacist will be available to compound the drug quickly enough to save the patient’s vision.”
“Further, Congress never intended for the FDA to assert regulatory authority over the traditional practice of pharmacy.”
Congressman Cuellar said, “This is a bipartisan, common sense bill that gives pharmacists and doctors the flexibility they need to treat patients and save lives.”
“The administration of compounded drugs is critical to dermatologists’ ability to provide proper and timely care to patients, many of whom suffer from chronic, disabling skin conditions,” said Henry W. Lim, MD, FAAD, president of the American Academy of Dermatology Association. “Unfortunately, under FDA’s restrictive interpretation of the DQSA, our patients are facing barriers in accessing timely and effective medical care. We strongly support efforts to clarify congressional intent of the DQSA, and commend Congressman Griffith and Congressman Cuellar for working to ensure physicians and patients continue having access to office-use compounded drugs.”