In an article written by Dr. Michael Carome, an expert on issues of drug and medical device safety and pharmacy compounding, the Huffington Post is calling Congressman Morgan Griffith’s proposed law, Preserving Patient Access to Compounded Medications Act of 2017, the “outrage of the month.” According to Carome the bill would “would eviscerate the critical patient safeguards established under the Drug Quality and Security Act (DQSA),” which was enacted after drugs containing fungal meningitis produced by the New England Compounding Center (NECC) reached over 13,500 patients, killing 76.
Briefly, the DQSA regulates compounding, where pharmacists combine, mix, or alter customized medications, a long-standing and accepted practice. Under the DQSA, compounding pharmacies can choose to register with the FDA, which obligates them to adhere to FDA quality standards but allows them to mass produce compounds. Or, pharmacies can decline to register, and not be subject to FDA standards, but then can only produce compounds when prescribed for specific patients.
Makes sense, right? Large pharmacies that want to operate like drug companies are subject to the same FDA regulations. Smaller pharmacies that want to fill individual prescriptions are not.
These are not abstract fears. In 2017, compounding pharmacy Pharmakon Pharmaceuticals was accused of creating compounds that were either stronger or weaker than advertised. Writes Dr. Terri Lewis in the National Pain Report, “Even after 13 infants, newborns in a neonatal care unit at an Indiana hospital received double-strength sedative from Pharmakon, the defendants continued to ignore safety notices from the safety companies that would tell them that their drugs were too strong.” Ultimately, three infants “received morphine sulfate that was nearly 25 times the strength indicated on the label, resulting in the airlifting of one infant to another hospital.”
Under the DQSA, 52 of 66 pharmacies that voluntarily registered with the FDA had been notified of potential violations by December 2016. Absent the requirements Griffith’s bill seeks to eliminate, few if any of these pharmacies mass producing compounds would have been inspected, and these problems would not have been found.
Despite these legitimate concerns, Griffith’s proposed bill would allow any pharmacy to mass produce compounded sterile drugs for hospitals and doctors’ offices without registering or adapting the FDA standards. According to Carole, the passage of the Griffith bill would” all but guarantee another public health catastrophe like the 2012 NECC-caused fungal meningitis outbreak.”
Why is Congressman Griffith so interested in compounding pharmacies? Clearly, he is well connected with the International Academy of Compounding Pharmacists (IACP), a trade group representing more than 4,000 pharmacists, as he delivered the keynote at the COMP Pac Fundraising Dinner in May 2014. He was also honored at a reception hosted by the COMP PAC & Arnold & Porter Partners PAC in April 2015, where suggested contribution levels ranged from $250 to $2500, with checks payable to Morgan Griffith for Congress.
Clearly, job number 1 for all elected officials is to get re-elected, and we’re not suggested that anything nefarious, or even unusual took place. But Congressman Griffith represents the Ninth District, and each legislator has limited bandwidth to write and argue for legislation. If passed, this bill will make our drugs less safe, and his last bill, fortunately, voted down by the House, would have gutted the Congressional Budget Office (CBO). This bill was formulated on behalf of the COMP PAC, and the CBO bill on behalf of the House Freedom Caucus.
At the same time, Senators Mark Warner and Tim Kaine came together to introduce a bill that will lower prescription drug costs for nearly 41 million seniors enrolled in Medicare Part D. Not only does this help citizens in the Ninth District, it helps citizens throughout Virginia and the United States. It’s time for Congressmen Griffith to start introducing bills that do the same.