Drug Safety as Job One

Recently, after getting her regular prescription for Synthroid filled at the pharmacy, my mother called the physician to complain that she just didn’t feel well. The doctor was considering increasing the dosage when my mother noticed that the pills looked different. She had been given a generic version. Her prescription was changed back to Synthroid and she felt fine again.

Calan was prescribed for a coworker with hypertension. Generic verapamil was dispensed, which controlled her blood pressure to 120/84 mm Hg. However, the next time the prescription was renewed, my coworker experienced a pounding headache. She then checked her blood pressure as she had been instructed to do by her physician; it was 140/94 mm Hg. The pharmacy had changed its generic drug supplier. It took a few phone calls from the physician to the PBM, but my coworker was finally able to get the cost of the brand-name drug covered.

More serious problems with generic drugs are being reported-and more frequently- according to Katherine Eban, a health care journalist who investigated the generic drug industry for 1 year. See her article “Bad Bargain: The Dangers of Generic Drugs” in the June issue of Self (http://www.self.com/health/2009/06/dangers-of-generic-drugs). Numerous complaints about generic drugs are also detailed on the Web site of the Peoples Pharmacy, which aired a radio show on this issue on June 6 (http://www.peoplespharmacy.com).

Eban begins the Self article with a report about a woman with a diagnosis of depression for whom Wellbutrin XL was prescribed, but her prescription was refilled with Budeprion XL. Within a month of taking the generic version, the 34-year-old suffered from extreme fatigue and other debilitating symptoms. Over 8 months, she saw 4 specialists, and 9 different medications were prescribed before, by chance, she connected the problem to the generic she had been taking. Within a week of discontinuing Budeprion XL and starting Wellbutrin XL, the woman’s symptoms disappeared. Subsequent independent laboratory testing revealed that the 300-mg Budeprion XL dumped 4 times as much of the active ingredient during the first 2 hours as the brand-name version.

Generic drugs now make up nearly 70% of all medications dispensed. From 2000 to 2008, the number of new generic drugs submitted for FDA approval went up 40% and approvals doubled, with approximately 600 cleared for sale in 2008. Continued reliance on generic drugs is an essential part of present and future health care reform and cost-containment efforts. The generic drug approval process is also viewed as a model for regulating “generic” versions of biologics, which are far more complex to manufacture.

According to Eban’s research, FDA oversight is lax and uneven at best. Inspections are infrequent, and the regulatory process is far from transparent. Compounding the problem is that many generic drug facilities are now located outside the United States, most notably in India and China. Currently, almost 90% of factories that provide active ingredients for new generic drugs are located overseas, says Eban.

Clearly, the FDA needs to step up its enforcement of safety issues and require bioequivalence testing beyond the mere filing of paperwork. Managed care companies, meanwhile, may want to rethink how they handle member complaints about generic drugs. Such complaints need to be taken seriously. After all, generics are only truly cost-effective if members benefit from their use.