The nation’s pharmaceutical lobby is vigorously opposing legislation before the D.C. Council intended to regulate drug-sales reps and the unapproved use of prescription medicine, claiming it will unnecessarily interfere in the relationship between doctors and patients.
For at least the second time in three years, the Pharmaceutical Research and Manufacturers Association is butting heads with Council Member David Catania over a major drug reform bill.
Catania’s newest measure requires that all pharmaceutical sales people earn at least a bachelor’s degree in pharmacy or science and hold a license issued by the D.C. Board of Pharmacy.
It mandates that physicians obtain written consent from a patient before prescribing a medication for a use not explicitly approved by the U.S. Food and Drug Administration.
And it demands disclosure of clinical-trial data to the D.C. government within 30 days of the end of the trial.
On the eve of today’s hearing in the council’s health committee, PhRMA claimed Catania’s measure is unrealistic and will do more harm than good.
The two have an adversarial past — a Catania bill to reduce pharmaceutical prices was struck down in federal court last year after the drug lobby sued.
The off-label use provision in Catania’s newest legislation is of particular concern, PhRMA says. Many medications that survived clinical trials for one ailment have been found useful for another.
“We think it’s more important for physicians to focus on making sure that patients know what they’re supposed to be doing in addition to taking medication, rather than walking through a discussion of whether a particular use is approved by FDA,” said Marjorie Powell, PhRMA’s senior assistant general counsel.
Catania shot back: “Though PhRMA may not feel our residents have a right to know when they are being prescribed a drug for non-FDA approved use, I believe that all patients deserve this information.”
As for sales reps, who Catania argues are subject to less regulation than a barber, Powell said they are well-trained by their respective firms.
“If you don’t have the mental capacity and the background to master an enormous amount of scientific information, you do not become a pharmaceutical sales representative,” Powell said.
