Markey introduces compounding pharmacy bill
Pharmacy works with Congress to seek solutions in wake of meningitis outbreak
Rep. Ed Markey (D-MA) on November 2 introduced proposed legislation called the Verifying Authority and Legality in Drug (VALID) Compounding Act that aims to increase regulatory oversight of compounding pharmacies.
“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” Markey said in a November 1 news release announcing the bill. His congressional district was home to the now-shuttered New England Compounding Center (NECC) facility linked to the meningitis outbreak that has led to 30 deaths and 419 illnesses in 19 states, according to the latest CDC update.
Markey’s announcement was accompanied by a letter of endorsement from Gov. Deval Patrick of Massachusetts, citing a “regulatory gap” and the need to “strengthen FDA’s oversight.” There was also a letter of endorsement signed by Cancer Prevention and Treatment Fund, Jacobs Institute for Women’s Health, National Consumers League, National Research Center for Women & Families, Our Bodies Ourselves, and Union of Concerned Scientists. Pharmacy did not appear on the list of signatures.
“We certainly don’t want to see anything like this to ever happen again. In preventing problems in the future it’s important regulators have the adequate resources to enforce existing laws and to strike the right balance between safety and patient access to compounded medications that they need,” Brian Gallagher, BSPharm, JD, APhA Senior Vice President of Government Affairs, told pharmacist.com. He noted that finding that balance is complex, requiring very nuanced solutions.
“To get to a specific solution, we need to understand the root cause of the problem,” Gallagher continued. “In this case, from all reports, it appears that NECC was manufacturing not compounding and enforcing violation of either existing state or federal law was not done. [State] boards of pharmacy and FDA are strapped for resources to conduct inspections and, at times, inspectors are not properly trained. One of the solutions is to provide more resources and better training.”
Pharmacist.com now has a new section called Just the Facts on Compounding. APhA will be providing ongoing updates, questions and answers, APhA news coverage, and other resources on compounding, including a fact sheet from the International Academy of Compounding Pharmacists.
Part of the regulatory gap referred to by Deval is that state boards of pharmacy oversee the practice of compounding and FDA has oversight for the medication ingredients used in compounding. The other part is that state boards of pharmacy regulate pharmacies and FDA regulates manufacturers. NECC crossed the line from pharmacy to manufacturing.
The first identified case of fungal meningitis, due to an epidural injection from contaminated lots of methylprednisone acetate compounded by NECC, came to CDC’s attention on September 21, pharmacist.com has reported. Since then, Members of Congress in both chambers and from both parties have sent letters to FDA and the U.S. Department of Justice. The U.S. House of Representatives Energy & Commerce Committee scheduled a hearing for November 14. The U.S. Senate Health, Education, Labor, and Pensions Committee scheduled a hearing for November 15. APhA has met with Members of Congress, their staff, and the relevant committees to discuss what happened, what compounding is, why it is important, and potential solutions, according to APhA Senior Lobbyist Michael Spira.
Markey issued a report, Compounding Pharmacies, Compounding Risk, on October 29. According to the related news release, the report “document[s] more than a decade of violations and problems at compounding pharmacies throughout the nation” caused by “regulatory oversight and gaps in legal authority.” “For years, the compounding pharmacy sector has resisted federal oversight and assured everyone that state regulators were adequately overseeing their activities,” Markey said in a statement. “This report demonstrates that this is simply not true.”
The November 1 news release from Markey’s office characterizes his proposed VALID Compounding Act as follows:
- Preserve state regulatory authority for traditional small compounding pharmacy activities
- Ensure that compounding pharmacies operating as drug manufacturers are regulated by FDA as drug manufacturers
- Allow compounding pharmacies with a legitimate reason to compound drugs before the receipt of a valid prescription to request a waiver to enable them to do so
- Allow FDA to waive the requirement to compound drugs solely for individual patients with valid prescriptions in the event of a drug shortage or to protect public health
- Allow FDA to waive the requirement to compound drugs only if they are not copies of commercially available drugs if doing so is necessary to protect public health or well-being
- Increase public transparency by mandating that compounded drugs be labeled to ensure recipients know that the drugs have not been tested for safety or effectiveness, publishing a “Do Not Compound” list of unsafe or ineffective drugs, and reporting of bad reactions to compounded drugs or any drug that poses a safety risk
Responding to Markey’s announcement, the National Community Pharmacists Association (NCPA) issued a news release November 1 that said NCPA was reviewing the bill and would formally provide comments to Markey’s office.
“Based on our initial review, certain provisions in the bill likely would help address the anomalies like NECC. Those provisions represent a solution to an identified problem,” John Coster, BSPharm, PhD, NCPA Senior Vice President for Government Affairs, said in the statement. “However, the proposed legislation also appears to create new overly broad requirements on traditional pharmacy compounding that could negatively impact both patients' access to essential medications and the community pharmacists who provide them.”
Coster continued, “As currently drafted, the legislation would grant new powers to an already stretched Food and Drug Administration to regulate traditional pharmacy compounding, and create new roadblocks for patients by requiring waivers for pharmacists to make medications that they have been making safely and effectively for decades.”