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More compounding-pharmacy recalls worsen the situation; FDA looks for new legislation
With some fanfare, FDA and industry groups announced expanded efforts to deal with drug shortages in late 2011, mostly (but not exclusively) involving generic products for injection. Manufacturers are now obligated to provide information of upcoming shortages to FDA (something many did voluntarily prior to passage of the FDA Safety and Innovation Act last summer). And while the Drug Shortage team at FDA undoubtedly is working hard to address shortages, overall, the situation is only marginally better, if that. On March 22, the shortages list maintained at the American Soc. of Health-System Pharmacists contained 241 products in short supply (a handful of these are actually containers or devices for delivering meds to patients). In late 2011, FDA Commissioner Margaret Hamburg noted that staff had addressed over 100 potential shortages. Back then, the shortage count was approaching 300. FDA’s site also lists 51 shortages that have been ameliorated in some fashion from early 2012 to early 2013.
The April 1 issue of the Am. J. of Health-System Pharmacy will have a survey, conducted by the Hematology/Oncology Pharmacy Assn. and authored by James Hoffman, PharmD, of the St. Jude Dept. of Pharmaceutical Sciences, showing that shortages of oncology products “are taking a heavy toll on cancer patients, forcing treatment changes and delays that for some patients mean worse outcomes, more therapy-related complications and higher costs,” according to a statement from Memphis-based St. Jude. “Unlike medications for other diseases, there are few, if any, therapeutically equivalent alternatives available for many oncology drugs in short supply,” says Hoffman. That study spanned the October 2010-October 2011 timeframe, but a look at the current ASHP list shows many of the same products are still there.
The shortages have consequences for innovator pharma companies as well: clinical trials involving comparator products have been disrupted or delayed—and there are hundreds of oncolytics in various stages of research. Whether generic or branded, though, the problem is a black eye for the entire industry. One of FDA’s recourses is to import “foreign” (its word) drugs on a temporary basis to address a shortage; the more frequently and the more prolonged this process is, the more it undercuts the US’s stance of not allowing non-US-controlled drugs into the US market.
Compounding the problem
Not much better news comes from a related, ongoing crisis involving compounded pharmaceuticals—again, especially with sterile injectables—following the outbreak of spinal meningitis in the second half of last year traced to the products of now-shuttered New England Compounding Center (NECC; Framingham, MA. The death count from that outbreak is now at 50). In November, another Massachusetts compounding pharmacy, under the same ownership as NECC, Ameridose (Westborough, MA), was voluntarily closed following state and FDA inspections and notices of production quality shortcomings. That facility, employing 700, remains shuttered, although a call to Ameridose on March 21 indicates that the company still expects to reopen, possibly by the end of April. FDA, when announcing the Ameridose shutdown, noted that “FDA is aware that the voluntary shutdown of Ameridose and the recall of Ameridose products may affect supplies of certain life-saving drugs for some health care systems. FDA has identified six Ameridose products on the FDA critical shortage list, which already were in shortage prior to the recall. The recall has the potential to exacerbate one or more of these shortages.”
In a March 22 blogpost, Commissioner Hamburg reiterated a call for federal legislation to oversee compounding pharmacies (which, like nearly all pharmacies, are regulated and overseen by state boards of pharmacy). She recounted the recent instance of a recall from Clinical Specialties (Martinez, GA), whose compounded Avastin, being used for macular degeneration (an off-label use disliked by Roche, which has a differently branded macular product, but acceptable to the ophthalmology profession due to Avastin’s lower cost), was found to be causing eye infections.
One potentially helpful industry effort, the so-called Accelerated Recovery Initiative from GPhA, was announced last year to monitor both the drug marketplace and the production backlogs at manufacturers, and thus forecast shortages before they begin. But apart from announcing that IMS Health would be the contractor to develop these analytics, no progress report or other public document has come out of GPhA since then.