Legal News

Generic v. Brand Drugs -- Will There Be Different Federal Standards?

By Brian Harris

By Adrianne Walvoord
Special to the Legal

In an attempt to dispel misconceptions about generic drugs, the FDA posted Facts and Myths about Generic Drugs on its website.  Fact: approximately 70 percent of all prescriptions are for generic drugs. Fact: research shows that generics work just as well as brand name drugs. Fact: on average, the cost of a generic drug is significantly lower than the brand name product. One reason generic prescriptions are likely on the rise is due to the increase in patent expirations, which has opened the prescription drug market to generic counterparts. 

Despite these facts, Consumer Report surveys in 2009 and 2010 showed that more than 40 percent of people said they had concerns about generic drugs, fearing that they weren?t as safe or as effective as brand-name medications, had different side effects, or came under different federal standards. 

I find the final point -- ?different federal standards? -- to be most interesting. As I discussed in my blog last month, the 9th U.S. Circuit Court of Appeals issued an opinion finding that a generic drug manufacturer?s duty to warn under state law was not pre-empted by federal law.  This opinion was in keeping with the 8th Circuit in Mensing v. Wyeth and the 5th Circuit in Demahy v. Actavis. 

So now we have three circuits applying the same federal standard to generic drugs as the U.S. Supreme Court did to a brand drug in Wyeth v. Levine. The Supreme Court, however, has granted appeals in Mensing and Demahy, which could put the rulings of the three circuits in jeopardy. On March 30, 2011, the high court will consider whether the state law failure-to-warn claims are pre-empted by the Drug Price Competition and Patent Term Restoration Act, fondly referred to as the Hatch-Waxman Act in honor of the act?s two sponsors. 

The Hatch-Waxman amendments facilitated the availability of generics by greatly reducing the burden on manufacturers to get a generic drug approved for sale. A generic manufacturer can file an Abbreviated New Drug Application (ANDA) to get approval for an existing licensed medication or approved drug. A generic drug is comparable to a brand drug in dosage form, strength, route of administration, quality, performance characteristics and intended use; however, a manufacturer of a generic drug is generally not required to include preclinical and clinical data to establish safety and effectiveness. In essence, a generic manufacturer can ride the coattails of the brand. 

Although it?s unlikely for the everyday citizen to contemplate the federal standards of pre-emption when deciding between a generic and brand prescription drug, the Supreme Court?s decisions in the Mensing and Demahy appeals may give rise to real concern. Will the Supreme Court find that a generic drug manufacturer may have a duty to warn above a brand manufacturer?  Or will the Hatch-Waxman Act pre-empt a state failure to warn claim against a generic manufacturer that uses the same label as its brand equivalent?  Stay tuned. 

Adrianne E. Walvoord is an associate at Anapol Schwartz Weiss Cohan Feldman & Smalley handling pharmaceutical and medical device litigation involving complex medical, scientific, and legal issues.  She practices in federal court, as well Pennsylvania and New Jersey state courts. She also currently represents juveniles affected by the Luzerne County Juvenile Detention Center scandal. Contact her at awalvoord@anapolschwartz.com.

Full post as published by The Legal Intelligencer Blog on February 25, 2011 (boomark / email).