|
Will off-label drug marketing soon be legal?
Cox II inhibitors were introduced into the U.S. market in the 1990s and quickly became blockbuster bestsellers, partially because of the marketing. At this time, federal officials were relaxing traditional standards that blocked most advertising aimed at consumers. The drug companies were also bombarding doctors with information about potential uses for the drugs, including some uses for which the medications had not been approved, an illegal activity at that time. Since 1962, pharmaceutical companies have been required to prove that their drugs are safe and effective for specific uses. Marketing drugs for unapproved, or "off-label" uses, is a criminal offense. However, that may be about to change as Allergan, Inc. (makers of Botox) has sued the U.S. Food and Drug Administration, claiming that the ban violates its free speech rights.
One thing should be noted: "Off-label marketing may be against the law, but off-label prescribing is perfectly legal, even common." About one in five prescriptions written in the U.S. each year is for an off-label use.
There is an apparent contradiction between how drugs are marketed and how they are prescribed, creating a gray area that opened the door for the Allergan case. Botox is widely used by plastic surgeons to treat wrinkles. In higher concentrations, it is approved to treat crossed eyes, eyelid spasms and some forms of dystonia. Additionally, some doctors use the drug off-label to treat muscle spasticity in adults who have had strokes and in children with cerebral palsy.
Allergan says it can't provide information about the benefits of off-label use without violating FDA regulations, so it filed suit to have those rules thrown out. Rightly or wrongly, doctors rely on pharmaceutical company marketing as an important source of information about drugs.
http://www.stltoday.com/stltoday/news/stories.nsf/editorialcommentary/story/
7242B8EDE96A2A79862577050082F594?OpenDocument
FDA approval results in an old gout drug getting a new, much higher price!
A drug that has been used for centuries to treat excruciating gout pain cost just pennies a tablet-until last year. Now, the retail price has skyrocketed to more than $5 per tablet, and some of the manufacturers have ceased production in a battle over marketing rights.
The common gout drug, colchicine, became the costlier branded drug (Colcrys), and the method of handling this drug offers insight into the questionable procedures of drug pricing. The FDA, in their efforts to document the safety of long-used drugs that have not been approved by the FDA, has created a situation between drug affordability and safety.
In July 2009, a Philadelphia drug manufacturer received FDA approval to exclusively market colchicine for three years to treat gout attacks. URL Pharma Inc. was taking advantage of a push to bring medicines predating the FDA (grandfathered drugs), like colchicine, under the agency's regulatory umbrella. The FDA offers exclusive marketing rights if a drug maker conducts clinical trials.
URL Pharma conducted the studies that confirmed its safety and efficacy and demonstrated that it should be taken at a lower dose than in the past and should not be used with certain other medicines. The company is marketing its drug as Colcrys with an average retail cost of $5 per tablet.
URL is suing the other manufacturers of colchicine saying the companies are now illegally marketing their products. In 2008, there were 3.5 million prescriptions and $6.4 million in sales.
The drug has been used for hundreds of years. For patients to suddenly have to pay $125 or $150 a month, after it only cost $5 or $10 a month, is a real problem. URL Pharma states that it priced Colcrys in line with other approved, branded drugs used to treat gout pain. URL's contribution did not involve a new therapeutic tool, was not new science; they just conducted clinical trials and increased their price.
The price increase is an unintended consequence of the FDA's nearly four-year-old initiative to regulate unapproved drugs. These medicines were sold before the FDA was established, and therefore weren't required to undergo approval; they were grandfathered in. After decades of use, the medicines are considered safe by doctors, but haven't been proven to satisfy the agency's standards. Colchicine's use has been traced back to the sixth century, according to the FDA.
http://online.wsj.com/article/SB10001424052748703630404575053303739829726.html?mod=dist_smartbrief
| 
