Infighting at Fed Threatens Marketing of Generic Drugs

Share this content:
A little known court ruling issued this month in Washington has outraged marketers of generic pharmaceuticals who are worried the decision may lead to the elimination of an important grace period that manufacturers said they need in order to compete effectively.


At issue is a federal decision handed down by U.S. District Judge Richard W. Roberts who ruled that the Food and Drug Administration has no authority to establish and regulate timing issues in relation to company launches of certain generic pharmaceutical products.


New and cheaper-priced generic drugs often come to market when a company begins filing for approval with the FDA even though the original brand manufacturer is expected to sue for patent infringement in the meantime. But if the hopeful generic manufacturer wins, it presumably needs a protective window in order develop its product line and marketing program to realize a reasonable return on its investment.


Carole Ben-Maimon, spokeswoman at Teva Pharmaceuticals USA, a unit of Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel, said the decision completely upsets rules that took a long time to negotiate. "It changes the way we do business, no matter how the FDA implements the rule ... because it puts pressure on companies to go to market earlier or lose the advantage of exclusivity, which they fought long and hard for."


Previously, the FDA had allowed first-time manufacturers of such drugs a 180-day jump-start period in order to pursue their initial marketing efforts before other competitors could enter the product category. There was also a motivational aspect to creating the grace period because it presented an attractive development opportunity to the manufacturers most likely to pursue development of generics.


But Roberts said the FDA did not act within its proper guidelines writing that "the FDA exceeded its authority" and acted in a fashion "contrary to the plain meaning" of its role as determined by Congress. However, his critics contend his ruling contradicts the plain meaning of the180-day window and how important it is for marketers. The plaintiff in the case was the generic division Mylan Laboratories, Pittsburgh.


The FDA said it is reviewing the decision.
close

Next Article in Marketing Strategy

Sign up to our newsletters

Company of the Week

Since 1985, Melissa has helped thousands of companies clean, correct and complete contact data to better target and communicate with their customers. We offer a full spectrum of data quality solutions, including global address, phone, email, and name validation, identify verification - available for batch or real-time processes, in the Cloud or on-premise. Our service bureau provides dedupe, email/phone append and geographic/demographic append services for better targeting and insight. For direct mailers, Melissa offers easy-to-use address management/postal software, list hygiene services and 100s of specialty mailing lists - all with competitive pricing and excellent customer service.

Find out more here »

Career Center

Check out hundreds of exciting professional opportunities available on DMN's Career Center.  
Explore careers in digital marketing, sales, eCommerce, marketing communications, IT, data strategies, and much more. And don't forget to update your resume so employers can contact you privately about job opportunities.

>>Click Here