PHARMACY

Congressmen say major drug companies falling short on DTC requests

BY Drew Buono

WASHINGTON According to House Energy and Commerce Committee chairman Rep. John Dingell, D-Mich. and Rep. Bart Stupak, D-Mich., chairman of the Oversight and Investigations Subcommittee, Johnson & Johnson, Pfizer, Merck, Schering-Plough and Pharmaceutical Research and Manufacturers of America have not gone far enough to accommodate congressional requests regarding direct-to-consumer advertising. The representatives had asked PhRMA and the four firms last month to comply with six specific requests.

After reviewing responses from all recipients this week, Stupak said, “Although we appreciate the drug companies’ willingness to change some of their business practices, they have not agreed to all of our requests, which would protect consumers from misleading and deceptive advertising.”

Dingell and Stupak asked PhRMA and the individual firms to:

  • Sign on to the American Medical Association’s (AMA) guidelines on the use of actors and health professionals in DTC ads; 
  • Not air DTC ads for any product until a valid outcomes study is conducted and its results released; 
  • Not air DTC ads for any new product for the first two years it is on the market, as recommended by the Institute of Medicine; 
  • Not encourage off-label uses in any DTC ad; 
  • Include the FDA’s toll-free MedWatch number in all DTC ads; and 
  • Include any black-box warnings in all DTC ads.

The second and third requests were the most problematic from the industry’s point of view. J& J, Pfizer, Merck and Schering-Plough said a six-month moratorium on DTC ads for new products is generally more appropriate than two years.

As to the second point, “a blanket requirement that DTC advertising await the completion and release of an outcomes study would prevent communication of treatment information to patients who could benefit substantially from controlling certain conditions such as high blood pressure,” Fred Hassan, chairman and chief executive officer of Schering-Plough, said.

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California information-sharing bill struck down by Assembly

BY Drew Buono

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.

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CCPA: track-and-trace mandate could cost pharmacies $110,000 per store

BY Alaric DeArment

ALEXANDRIA, Va. Implementing a track-and-trace system would cost drug store chains $84,000 to $110,000 or more per store in the first year, according to a study that examined the safety of the prescription drug supply chain and the potential effects of a federally mandated system.

The study, released by the Coalition of Community Pharmacy Action, examined the safety of the prescription drug supply chain and the potential effects of a federally mandated track-and-trace system. It also found that existing security measures since 2005, including changes in state laws and steps the chains themselves have taken, have already cut the risk of counterfeit drugs entering the supply chain. The study found no cases of counterfeit drugs in the normal distribution channels since 2005, and most of the problems were from Web sites distributing drugs illegally.

The cost estimate was based on costs of computer hardware software, infrastructure, labor and other resources.

The CCPA is comprised of the National Community Pharmacists Association and the National Association of Chain Drug Stores.

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