The 25 dead and hundreds sickened by tainted drugs made at a Framingham company do not represent the first occasion in which the largely unregulated compounding industry has caused harm, according to a report from US Representative Edward J. Markey.
Not including the recent fungal meningitis outbreak, problematic practices at compounding pharmacies have been associated with at least 23 deaths and 86 cases of serious illness, according to the congressman’s report, which cites Food and Drug Administration records and media reports.
Generally, state agencies are not equipped to regulate compounding pharmacies, and regulatory efforts by the FDA “have been challenged at every juncture by some members of the compounding pharmacy sector,” according to the report, which was released Monday.
“The risks of allowing the safety of compounding pharmacies to go largely unregulated have been recognized for years, but a patchwork of state regulation; incomplete and often inaccessible information about serious health issues caused by compounding pharmacies; and industry efforts to thwart better government oversight have complicated efforts to understand the true scope of this problem,” said Markey in a statement.
The industry became a focus of state and federal regulators earlier this month when a rare outbreak of fungal meningitis was traced to injections of methylprednisolone acetate produced by New England Compounding Center, a Framingham company that was allegedly operating outside its license and with subpar cleanliness standards.
Since then, state regulators have secured the temporary closure of Ameridose, a compounding company that shares ownership with New England Compounding Center, and more recently shut down Infusion Resource, a Waltham compounding company that was found to be operating outside its license and where “inspectors expressed concern for the sterility of product,” according to Bureau of Health Care Safety and Quality Director Madeleine Biondolillo.
As of Saturday, the Centers for Disease Control recorded 344 cases of fungal meningitis and 25 deaths in 18 states.
According to Markey’s office, the FDA has attempted to “rein in” the industry since 2001, recording a host of violations, including the manufacturing of commercially available drugs, the use of non-FDA-approved ingredients in drug manufacturing, manufacturing large quantities of drugs, and making drugs in facilities that are “visibly dirty.”
The compounding industry is distinct from the pharmaceutical industry. The International Association of Compounding Pharmacists notes on its website that compounders craft doses of drugs for a specific patient’s needs.
“Whether it’s an allergy to a dye or ingredient, a need for a different strength, or a preference for a different dosage form, compounding pharmacists provide patients with solutions to their medication needs,” the association wrote. The association also noted that the compounding center apparently “exceeded its scope of authority as a pharmacy and engaged in the manufacture and distribution of prescription drugs.”
In response to Markey’s report, the association said inspections should be a regular occurrence for pharmacies.
“Any pharmacy in the US can be inspected at any time by either the FDA or state authorities. Now we must make sure that happens,” the statement said. “Compounding pharmacies do not fear inspections, they expect them. IACP and its members have been regularly meeting with members of Congress and their staff and will continue to work closely with them as legislation is filed. Beyond existing and potential new laws and regulation, we need to ensure that enforcement by the regulatory agencies is occurring.”
According to Markey, both state and federal regulators are unequipped to regulate the industry.
“This analysis makes clear that state regulators are not, or cannot, perform the same sort of safety-related oversight of compounding pharmacy practices that FDA has historically undertaken,” Markey’s report states. “But it is also clear that absent clear new statutory authority, FDA’s efforts will ultimately be constrained by gaps in regulatory authority and thwarted by an industry that has historically resisted a federal role for the oversight of its activities.”
Governor Deval Patrick has suggested more broad-ranging oversight on the industry in Massachusetts.