California information-sharing bill struck down by Assembly
LOS ANGELES A California bill aimed at sharing people’s prescription medication information with mass mailers did not receive a single vote of support in the Assembly Health Committee after being approved by the Senate on May 29, according to the Los Angeles Times. The bill, SB 1096, was written by Sen. Ron Calderon, D-Montebello, who will most likely not reintroduce it, even though he reserved the right to do so.
In presenting the legislation Tuesday, Calderon described it as a boon to consumers, especially those with chronic medical conditions. He said it would allow drugstores to send letters to people reminding them to take their medication or refill a prescription.
The problem with the bill, besides the fact that the patients did not want their prescription medical history shared with someone other than their doctor, is that the bill did not state who would be paying for the reminder letters and which patients would receive them.
According to the Times, it appeared that pharmaceutical companies were behind the funding in an effort to bring in more money on their respective medicines. Also, another provision stated that people who wanted to not be on the mailers would have to opt-out of the program, instead of opting into the program by stating that they would be okay with their information shared.
Major drug companies agree to six-month moratorium on DTC ads
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.
FDA grants Mylan approval for generic Avalide application
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.