In a move to resist opposition from the Big Pharma on the Authorised Generics Bill and the 180-day exclusivity period offered to the first abbreviated new drug application (ANDA) filer, the Generic Pharmaceutical Association (GPhA) has called the latest study of the Pharmaceutical Research and Manufacturers of America (PhRMA) on authorised generics as disingenuous.

The GPhA, the American organisation of generic drug manufacturers, slammed the Big Pharma organisation PhRMA, saying that the brand companies are increasingly deciding to circumvent Congressional intent, which allowed 180 days period exclusivity to generic companies through Hatch-Waxman Act, by bringing authorized generics to market. This blatant move to cut the legs out from under Congressional intent only serves to harm consumers by stifling competition.

"No one should be fooled by PhRMA's latest attempt to pull the wool over consumers' eyes. Instead of focusing on what brand pharma claims its mission is - to develop innovative drugs - it has decided to spend its time undermining the value of the 180-day generic exclusivity provision. That's bad for consumers any way you look at it. They know the more they devalue the 180-day generic exclusivity provision, the less of a chance generic companies will undertake questionable patent challenges in the future," said GPhA president and CEO Kathleen Jaeger.
Brand pharma is simply focused on abusing every loophole it can find in search of greater profits and to maintain a brand name drug monopoly. It's a strategy aimed at protecting brands' bottom lines, not consumers' pocketbooks, added Jaeger.

Under provisions in the Hatch-Waxman Act, the first generic company to successfully challenge a questionable brand patent, file an abbreviated new drug application (ANDA) with FDA and receive approval to market that drug product is awarded 180-day exclusivity. This 180-day period was designed to permit the generic company alone to compete with the brand company, allowing the generic to recoup costs incurred for undertaking a patent challenge. Brand companies can compete with the generic in this exclusivity period by introducing an authorized generic, which is the brand's own product repackaged and marketed either through a subsidiary or third-party.

The GPhA has already alleged that the authorised generics could severely curtail future patent challenges, if allowed to remain unchecked by Congress. The association also fears that the trend would allow brand companies once again to evergreen patents and substantially delay consumer access to affordable medicine.

The incentive to challenge patents has already saved consumers tens of billions of dollars by enabling the introduction of generic competition earlier than otherwise would have been possible. Jaeger said, "GPhA strongly urges Congress to close the authorized generic loophole and restore the careful balance achieved by the Hatch-Waxman Act. Preventing the introduction of authorized generics during the exclusivity period will ensure that consumers continue to receive timely access to safe and effective generic medicines."

Generics represent 63 per cent of the total prescriptions dispensed in the United States, but less than 20 per cent of all dollars spent on prescription drugs.