FDA Ensures Equivalence of Generic Drugs

By Yorke, Jeffrey | FDA Consumer, September 1992 | Go to article overview

FDA Ensures Equivalence of Generic Drugs


Yorke, Jeffrey, FDA Consumer


When Stuart Addison goes to the pharmacy in Margate, Fld., he has the pharmacist fill his prescriptions with generic drugs. Addison. a retired federal government auditor, is one of many Americans who are choosing genetics when they buy drugs.

"My motivation is to keep the prices down," said Addison, noting that his insurance plan pays for his prescriptions. "My pocketbook is not directly affected, but in the long run, I'm helping to keep down insurance premiums."

Although not all approved drugs are available

in a generic version, those that are can offer substantial savings to consumers. For millions of Americans, the less-expensive drugs could mean the difference between getting necessary therapies and not being able to afford proper medical treatment.

Insurance companies' recommendations to policy holders that they choose genetics over brand-name drugs whenever possible, coupled with the promotional efforts of large drag chains, have helped heighten consumer awareness of the availability of generics. The result has been that genetic sales have been booming most of the years since 1984, when Congress passed the Drug Price Competition and Patent Term Restoration Act. This act expanded the number of drugs eligible to be manufactured as genetics. The new rules eliminated the need for duplicate safety and efficacy testing for genetics, saving industry time and money. The Food and Drug Administration also developed and issued explicit guidelines for a genetic product's bioequivalency (see accompanying article) and stability, ensuring that products retain potency. In addition, products must meet specifications set by the U.S. Pharmacopeial Convention, a private scientific organization that sets standards for drugs and drug products in the United States. Almost 80 percent of U.S. generic drug production is done by brand-name firms in modem manufacturing plants.

In 1991, consumers spent about $5.5 billion for generics and are expected to spend more than $15 billion in 1995, according to a report issued earlier this year by Frost & Sullivan International, a health information research organization. The report found that expiring patents on pioneer (brand-name) drugs, coupled with increased attention to containing health-care costs, will play important roles in the growth of the generics industry in the next decade.

Since 1984, there has been a succession of top-selling chugs that have lost their market exclusivity and been challenged for market share by genetic brands. An average of about 15 pioneer drugs lose patent protection annually, and FDA has prepared for an expected explosion of new generic drug applications through the end of 1995. Among the top-selling brandname drugs scheduled to lose protection are Eli Lilly's anti-infective Ceclor, Marion Merrell Dow's calcium channel-blocker Cardizem SR, and the firm's nonsedating antihistamine Seldane. Also scheduled to lose their exclusive market niche are the anti-inflammatories Anaprox by Syntex and Voltaren by Geigy, hypoglycemics Glucotrol by Roerig and Micronase by Upjohn, and Squibb's antihypertensive Capoten.

Scandal Rocks Industry

Popularity of the copycat products grew significantly after 1984, when the approval process was widened. But that popularity took a downturn in 1989, when scandal rocked the industry. Federal investigators uncovered such problems as illegal gratuities, fraud, obstruction of justice, and noncompliance with various manufacturing procedures by some industry officials.

The investigations revealed that several FDA employees had accepted money or other compensation in exchange for information and assistance that gave certain firms an advantage in the approval procedure. Investigators also uncovered submissions of fraudulent data by several manufacturers. In one case, a company submitted the pioneer drug disguised as a genetic version with its bioequivalence studies. …

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