PHARMACY

State proposals try to prohibit automatic generics replacement

BY Drew Buono

WASHINGTON Brand pharmaceutical companies are taking their war with their generic counterparts to the state level, by promoting proposals that would prohibit pharmacists from automatically replacing certain brand-name drugs with generic alternatives, according to the Baltimore Sun.

The legislation being pushed at the state level would make the exchange more difficult by requiring pharmacists to inform doctors or get their permission before substituting a generic version of a brand-name drug.

Measures favorable to the brand companies have been considered by 27 states and approved by two—Utah and Tennessee—over the past year, according to the National Association of Chain Drug Stores, which opposes the changes.

While some proposals apply to any kind of prescription drug, most take aim at particular classes of medicines, such as drugs to suppress a patient’s immune system after a transplant or to curb epileptic seizures.

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Major drug companies agree to six-month moratorium on DTC ads

BY Drew Buono

WASHINGTON Under pressure from some of the top members of the House of Representatives, top drug companies, including Merck, Johnson & Johnson and Pfizer, are agreeing on a six-month moratorium on advertising new drugs to consumers and will limit how doctors are used in their ads, according to reports.

The changes were unveiled in letters the manufacturers sent the House Energy and Commerce Committee responding to a request from committee chairman John Dingell, D-Mich., and Rep. Bart Stupak, D-Mich., who head the committee’s oversight and investigations panel.

Dingell and Stupak had wanted the companies to impose a two-year voluntary moratorium on advertising of new prescription drugs to consumers – and possibly even longer in the case of drugs for which not all studies have been completed. The lawmakers also asked the drug companies to limit the use of doctors in their advertising and agree to “black box” warnings on ads if the Food and Drug Administration requested them.

In the letters, executives of J&J, Merck, Merck/Schering-Plough and Pfizer agreed to take several steps, while the Pharmaceutical Research and Manufacturers of America agreed to hold further meetings with the committee. The companies will start following the American Medical Association’s guidelines about using actors to portray doctors, and at least one marketer, J&J, said it would not use doctors in ads to discuss the benefits of a drug.

The drug companies said in their letters that the six-month moratorium formalized industry practice, which is to educate doctors before moving to consumer communications. “We drugs [that] requires that our operating companies spend at least six months after approval have adopted internal guiding practices on direct-to-consumer advertising for prescription of a new medicine educating health professionals before commencing a direct-to-consumer advertising campaign,” wrote William Weldon, chairman and chief executive officer of J&J. He added that the company “does not believe a particular fixed period of time for an advertising moratorium is appropriate in all circumstances.”

Dingell and Stupak said they were pleased with the response, but wanted the drug companies to go further, with a two-year limit.

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FDA grants Mylan approval for generic Avalide application

BY Alaric DeArment

PITTSBURGH The Food and Drug Administration has granted tentative approval to Mylan Pharmaceuticals for its application for a generic version of Sanofi Aventis’ Avalide Tablets.

The tablets, generically known as irbesartan and hydrochlorothiazide, are used to treat hypertension. The application is among the 92 that Mylan has submitted to the FDA for approval.

Avalide had U.S. sales of about $288 million for the 12 months ended March 31, according to IMS Health.

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