In the wake of the recent fungal meningitis outbreak, lawmakers are calling for stricter oversight of compounding pharmacies. As of October 13, 2012, at least 197 people had been sickened and 15 had died in the outbreak, which resulted from epidural pain injections that combined numbing agents with contaminated steroids. The steroid involved, methylprednisalone acetate, was prepared by the New England Compounding Center and delivered to pain clinics in 23 states. That fact is troubling to many who believe that compounding pharmacies, like the New England Compounding Center, are operating outside of their scope.
Compounding pharmacies were not created for the wide-scale manufacture and distribution of drugs. Instead, they began as local pharmacies or pharmacists who mixed ingredients to make drugs that were tailored toward specific, individual needs. For example, pharmacists could make lower dosages of adult drugs for children or omit inactive ingredients, such as dyes, from drugs for consumers with allergies. They could also mix drugs that were not available for commercial use. Because they mixed drugs only for patients with specific prescriptions, there was limited concern over the safety of a drug for a particular patient. For that reason, drugs created at compounding pharmacies have never needed to undergo the rigorous Food and Drug Administration (FDA) approval process. The FDA still values the services that legitimate compounding pharmacies provide to individual consumers. However, when compounding pharmacies straddle the line between compounding and manufacturing, their freedom from FDA guidelines becomes a cause for concern for the agency.
The FDA has limited control over compounding pharmacies and generally limits its enforcement focus to those that are actually operating as drug manufacturers. Congress passed the Food and Drug Modernization Act of 1987 to clearly define compounding pharmacies’ rights and to differentiate between compounding pharmacies and drug manufacturers. However, in 2002, the U.S. Supreme Court determined that the advertising portions of the Act unconstitutionally restricted free speech and invalidated the entire statute. In the wake of the decision, the FDA published a May, 2002 Compliance Manual, in which it laid out a list of nine factors it would consider when deciding whether to take enforcement action against a compounding pharmacy. These included:
- (1) compounding drugs, except in limited quantities, in anticipation of prescriptions;
- (2) distributing significant amounts of products out of state;
- (3) using commercial-scale manufacturing or testing equipment for products;
- (4) preparing drugs for third parties who resell them to patients or providing drugs at a wholesale rate to individual or commercial third parties who resell them; and
- (5) compounding drug products that are commercially available or that are copies of commercially available drugs.
New England Compounding’s operations would have raised red flags to anyone examining the company. The business, which has since closed its operations and recalled all of its products, produced drugs on a large scale, distributing them out of state. In fact, the pharmacy employed sales representatives who went so far as to fly out of state to meet with potential clients. Methylprednisalone acetate, the contaminated steroid at issue in the recent outbreak, is essentially a copy of an FDA-approved drug. Understandably, some medical providers were attracted to the company because it provided drugs at a significantly lower rate than other manufacturers. For example, New England Compounding charged one provider $25 for five doses of the injection, whereas Depo-Medrol, produced by Pfizer, sells for roughly $40-46, according to an article in the New York Times.
Lawmakers are calling for stronger federal oversight of compounding pharmacies. Representative Edward Markey (D-Mass.), for example, plans to introduce legislation that will require compounding pharmacies to adhere to minimum safety standards and report adverse events to the FDA. It would also require consumers to be warned that compounded drugs are not FDA-approved. Representative Rosa DeLauro (D-Conn.) plans to present her own bill. In a letter to the FDA, Senator Richard Blumenthal (D-Conn.) said of compounding pharmacies, “Their relative immunity from standards of safety and effectiveness seems anomalous and unacceptable. The FDA’s authority should be extended if necessary to make and enforce stronger standards that protect the public and assure quality.”