July 6, 2001 (Washington) — The battle over soaring prescription drug prices has several active fronts. Buses of senior citizens bound to Canada for cheap drugs have become classic media images reflecting Americans’ concern over the high prices they face for crucial medications.
In fact, those border trips prompted Congress to pass ill-fated legislation allowing Americans to re-import prescription drugs bought more cheaply in other countries.
More recently, the Food and Drug Administration is now deciding whether several well-known prescription allergy drugs — Allegra, Zyrtec, and Claritin — are safe enough to be sold over-the-counter.
And there’s the continuing national issue of adding a Medicare drug benefit.
But there’s yet another zone of dispute: generic drugs. And it’s complete with a handful of colorful jargon critical of the powerful but increasingly beleaguered brand-name drug industry.
In 2000, the average brand-name medication cost $65.29, while the average generic drug cost just $19.33, according to IMS Health, an independent company that tracks the pharmaceutical industry.
When and how generic drugs can enter the market has attracted recent attention. Patents generally protect brand-name drugs for 20 years, during which time no other company can develop and sell a replica, or generic version, of the drug.
But brand-name drugmakers have found ways to extend their patents — sometimes for an additional five years — using “patent stacking” or “submarine patenting,” which further delays the introduction of generic versions.
Bipartisan legislation is pending in both the House and Senate to reform Hatch-Waxman, the nation’s 17-year-old drug patent law. The new bill aims to speed generic drugs into the market.
According to Sens. Charles Schumer (D-N.Y.) and John McCain (R-Ariz.) who crafted the new Senate bill, the measure could save consumers $71 billion over the next 10 years.
The bill would attack patent stacking or submarine patents, which describe when drugmakers file for any of a number of last-minute patents related to how their brand-name drug is manufactured, packaged, or even how many grooves are in the pill. These slight modifications often result in patent extensions.
The Federal Trade Commission also is evaluating generic drugs. They are investigating whether generic competition is being unfairly blocked.
For example, the antianxiety drugs Paxil and Buspar, as well as the blockbuster heartburn drug Prilosec, have sparked legal battles as manufacturers of generic versions seek to enter the market.
Under the current law, if a generic maker goes ahead and markets its generic version, the brand-name drugmaker can file suit, which automatically blocks the generic from entering the market for another 30 months.
The chain drug stores support the generic access bill, as do health insurers, prominent consumer advocacy groups, and Ford Motor Co.
But the brand-name drug industry is strongly opposed to the proposed changes. Between 1984 and this past January, it notes, less than 6% of generic drug applications raised any patent issues.
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