Generic drugs have become a huge business. As prices for brand name medicines skyrocket, people are looking to generic equivalents to save money.
Over the last two decades the market share of generics has increased to almost 50 percent of all prescriptions. Although the cost of generic drugs is rising rapidly, they are still cheaper than their branded counterparts.
On average, a generic prescription costs around $15 while a brand name prescription averages $77. For example, you might pay $55 for 30 pills of the blood pressure medicine Tenormin while the generic, atenolol, would only cost about $8.
Such savings get people’s attention. Even President Bush supports regulatory changes to bring generics to market faster. State Medicaid programs, HMOs and insurance companies all promote low-cost generic equivalents.
But how reliable are generic drugs? This question has been debated for decades. Initially the big brand-name companies raised questions about generic quality. When they started making generics themselves, the discussion died down. But the issue hasn’t gone away.
FDA examines generic drugs carefully during the initial approval process. Companies must demonstrate that their copies are bioequivalent (get into the blood stream in a comparable manner to the pioneer product).
But who monitors to ensure continued quality standards? This responsibility lies, not with the Office of Generic Drugs, but with different branches of the FDA, the Offices of Compliance and Post-Marketing Surveillance. And that is where things begin to get very confusing.
In other industries where safety is at stake and where there may be an incentive for fraud, the government takes pains to carry out regular inspections. The Federal Aviation Administration inspects aircraft for defects that might affect passenger safety. Customs inspectors check luggage for plant materials that might carry insect pests or diseases, not to mention other illegal items. New buildings, old elevators and all restaurants are inspected on a regular basis.
But the FDA relies mostly on the honor system. Although inspectors are supposed to visit each drug manufacturing plant every two years, the agency does not have the manpower or resources to accomplish this task. Consequently, several years may pass between visits. Shady operators may not be scrupulous about maintaining standards in the interim.
In addition, although some products are randomly tested each year, they amount to a relative handful. The agency informs us that they analyze about 300 “finished dosage forms” annually, including both branded and generic medicines. That represents approximately 0.00001 percent of the 3 billion prescriptions filled in community pharmacies each year.
The only way the FDA can tell if there is trouble with a generic medicine is if physicians, pharmacists and patients report problems they experience. If you suspect a generic you took was not up to standard, we will pass your story along. Reach us by email (pharmacy(at)mindspring.com) or by mail: People’s Pharmacy (Dept Generic); PO Box 52027; Durham, NC 27717-2027.