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Distinguishing between pharmaceutical manufacturing and pharmacy compounding remains a policy conflict
While the 112th Congress was paralyzed by the “fiscal cliff” negotiations almost up to its last day in existence, little beyond blame-game theatrics occurred during Senate and House hearings with FDA over the ongoing meningitis outbreak caused by contaminated injectables produced under unsanitary conditions at New England Compounding Center (NECC) during the first half of 2012. As of Dec. 28, according to regular updates by the Centers for Disease Control (CDC) and FDA, the death toll had reached 39; there were 656 injured patients, and 372 confirmed cases of meningitis. Over 14,000 patients are at risk (NECC had produced some 17,000 dosages of methylprednisolone acetate—a steroid used for, among other things, pain control for spinal injuries).
CDC has opened a “Clinical Consultation Network” for clinicians needing advice on taking care of patients; in December it also issued a bulletin that some patients not suffering from meningitis could be harboring infected abscesses in their spines or joints—a serious and potentially debilitating situation.
In mid-December, FDA held a public hearing with state boards of pharmacy representatives, where Margaret Hamburg, FDA Commissioner, reiterated her desire to obtain new regulatory authority to distinguish “traditional” compounding (the common practice by individual pharmacies to tailor a prescription to a specific patient, such as by turning a tablet into a drinkable liquid) from “nontraditional” compounding pharmacies, which produce multiple dosages at any given time. The latter are supposed to be performed for individual prescriptions; producing multiple dosages without a prescription is tantamount to manufacturing—but the compounding pharmacies performing such a practice have a trail of federal court injunctions hampering FDA oversight.
Pharma manufacturers’ associations have been quiet as this scandal unfolded over the fall. Neither PhRMA, BIO nor GPhA has issued a statement. The pharmacy associations, NACDS and the National Community Pharmacists Assn. (NCPA; Alexandria, VA), have emphasized their members’ differences from largescale compounders and identify themselves as “traditional” compounders. A mid-November survey of 400 independent pharmacies by NCPA found that 85% of members engaged in compounding, and 72% engaged only in non-sterile formulations (i.e., not the sterile injectable such as methylpredinisolone). That same survey showed that 62% of those surveyed said that compounding makes up less than 5% of their revenue—which leaves open the question whether some of them generate substantially more than 5% from the practice.
The International Academy of Compounding Pharmacists (Missouri City, TX) issued a position statement in early December that pointedly stresses state-level pharmacy-board inspections; it has long maintained that as its members are pharmacists, FDA has no standing with them. The statement also calls for adequate funding of state boards.
Both Rep. Edward Markey’s VALID (Verifying Authority and Legality In Drug compounding) Act, and a bill introduced by Rep. Rosa DeLauro (D-CT), the S.A.F.E. Compounded Drugs Act, wound up in a subcommittee, where they sat and will need to be reintroduced in the next Congress. Markey’s somewhat wider-ranging bill specifies FDA inspections under some conditions, but leaves the definition of “nontraditional” pharmacies up in the air (except to specify that pharmacies sending compounded product across state lines might be subject to inspection). Hearings held in November seemed to focus primarily on holding FDA Commissioner Hamburg to account for failing to follow up on earlier warnings (some issued by FDA itself) about NECC.
In preparation of the December FDA public hearing, Public Interest, the Washington, DC consumer advocacy group, sent a letter to HHS Commissioner Sibelius tearing into FDA for lax enforcement of existing authority. It also called for an independent investigation of CMS, claiming that CMS’ Medicare-reimbursement policies may in fact have spurred the production of compounded products like the steroid.
"By failing to use [its reimbursement authorization policies], CMS essentially has encouraged pharmacies to produce such medications at dangerously large scales,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, in a statment. “An independent investigation is necessary to determine exactly how these policies contributed to the current meningitis outbreak and to prevent a similar tragedy from happening in the future.”
Given all the finger-pointing, it’s hard to say that substantive change will come out of the NECC scandal. But pharma manufacturers should be engaged; there have been occasional conflicts between manufacturers with branded products and compounding pharmacies that offer alternative products; in recent years, Eli Lilly was disputing the efficacy of “natural” hormone replacement therapy over its branded product; Genentech with less-expensive, compounded Avastin (bevacizumab) being used in place of its branded macular degeneration product, Lucentis (ranibizumab; both it and bevacizumab are angiogenesis inhibitors); and KV Pharmaceutical which went bankrupt trying to market an FDA-approved product, hydroxyprogesterone caproate, for which a cheaper compounded version was available. Moreover, as IACP’s position statement noted, it supports state boards of pharmacy monitoring “all pharmacy practice sites that conduct sterile compounding,” including hospitals, long-term care facilities, hospice, home infusion and specialty pharmacies—the latter of which is a key growth area for manufacturers.