HEALTH

CVS celebrates entry into Omaha

BY Antoinette Alexander

WOONSOCKET, R.I. —CVS/pharmacy recently celebrated its foray into the Omaha, Neb., market with a ribbon-cutting ceremony at one of its two new stores. It plans to open additional locations in the coming years. Omaha is the latest market that CVS/pharmacy has expanded its presence to in 2010—other markets include St. Louis; Memphis, Tenn.; and Puerto Rico.

As part of the grand opening celebration, CVS/pharmacy announced that it signed on as a Silver Sponsor of the ALS Association’s three Walk to Defeat ALS events in the state of Nebraska. CVS/pharmacy is a longtime supporter of the fight against amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease.

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CMPI survey: Alcohol, marijuana biggest substance problems among teens

BY Michael Johnsen

NEW YORK The Center for Medicine in the Public Interest on Thursday released the results of a national Teen Substance Abuse survey, indicating that police officers and high school teachers nationwide believe alcohol and marijuana are the most serious problem substances facing teenagers.

The results were released one week prior to a Sept. 14 Food and Drug Administration Advisory Committee meeting called to discuss whether or not additional sales restrictions need to be placed on dextromethorphan, a popular cold remedy ingredient that has been associated with teenage drug abuse. According to the survey, police and teachers polled do not believe it is a good idea to force Americans to visit a doctor to get a prescription to purchase commonly-sold cough-cold medicines.

When asked which substances do pose the greatest negative impact on teens, teachers and police identified marijuana and alcohol, followed by methamphetamine and cocaine. More than 1-in-4 police officers (27%) identified prescription drugs acquired by teens as having the greatest negative impact on teens, as compared with 15% of teachers. Nonprescription medicines were named by 1% of police officers as having the greatest negative impact; 2% of teachers identified over-the-counter medicines as such.

The survey also revealed that by a margin of 2-to-1, police officers and high school teachers support education efforts as a means to address abuse of OTC cough-and-cold medicines, versus restricted accessibility to consumers.

“Americans expect to be able to buy cough medicines conveniently at the supermarket or their neighborhood corner store,” stated CMPI VP Robert Goldberg. “Overly restricting access to cough-and-cold products containing dextromethorphan will create more health problems than it will solve, especially during cold-and-flu seasons. We need to find common sense solutions and invest more resources in education.”

The entire Teen Substance Abuse survey is available at Cmpi.org.

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Appeals court upholds decision to OK ‘pay-for-delay’ deals

BY Alaric DeArment

NEW YORK The federal government got a kick in the face Thursday as an appeals court ruled in favor of patent litigation settlements between branded and generic drug companies.

The U.S. Second Circuit Court of Appeals in New York decided not to reconsider a ruling it made earlier this year in the case of Arkansas Carpenters Health and Welfare Fund vs. Bayer AG. The case concerned the legality of a settlement between Bayer and Teva Pharmaceutical Industries subsidiary Barr Labs over the anthrax treatment Cipro (ciprofloxacin), but the court ruled that the deal between the two companies did not violate antitrust laws.

 

The appeals court’s decision is a major setback for the efforts of the Federal Trade Commission and members of Congress who have sought to ban such settlements.

 

 

In most cases, a generic drug company that wishes to market its version of a drug before the branded drug company’s patents expire will file an approval application with the Food and Drug Administration with a paragraph IV certification, a legal assertion that the patents covering the branded drug are invalid, unenforceable or won’t be infringed by the generic drug. In response, the branded drug company usually will sue, but cases frequently result in settlements whereby the generic drug company agrees to hold off launching its drug in exchange for payment of some sort by the branded drug company.

 

 

This often comes in the form of an agreement not to use an authorized generic, essentially the branded drug marketed under its generic name, to compete with the generic drug company during its customary six-month market exclusivity period. Legally, the generic company must launch before the patents expire or as soon as they do, and delaying launch after patent expiry would be illegal, though critics such as the FTC and The New York Times’ editorial board have often derided the settlements as “pay-for-delay” deals, with the FTC contending that they cost consumers billions of dollars a year. Nevertheless, most cases that are settled result in launch of the generic drug ahead of patent expiry. In the case of Bayer and Barr, Bayer paid Barr $400 million to hold off launching its version of Cipro.

 

 

“Patents, issued by the government, are given the presumption of validity,” read a statement from the Generic Pharmaceutical Association, the generic drug industry’s main lobby. “Any market entry of a generic drug before the brand patent expires –– whether as the result of a finding that the generic product does not infringe the patent, that the patent is not enforceable or through a patent settlement agreement with the brand company –– is a positive, cost-saving event for consumers.”

 

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