Bad news for pharma:
The Federal Trade Commission on Wednesday announced that it plans to subpoena 190 drug companies in an investigation of possible anti-competitive practices in the pharmaceutical industry, the AP/Los Angeles Times reports. The subpoenas, which require approval from the Office of Management and Budget, would be part of a probe into whether pharmaceutical companies are suppressing competition by releasing authorized generic versions of their own brand-name drugs to coincide with the introduction of products from generic drug makers. Under federal law, after a generic pharmaceutical company successfully challenges a patent held by a brand-name manufacturer, it has six months of exclusivity to sell the drug in the generic market by itself. However, a loophole allows brand-name manufacturers to authorize their own generic versions, which increasingly are entering the market at the beginning of the six-month exclusivity period. Generic drug manufacturers depend on that exclusivity period to recover their costs and make a profit, but with authorized generics entering the generic market sooner, profit margins are falling for generic manufacturers.
If definitely appears that this is an industry-wide practice, given that such a large number of firms are receiving subpoenas.
MHRA - In whose Interests?
The recent TeGenero drug trial debacle was an accident waiting to happen. As long as the Pharmaceutical Industry continues to suppress clinical trial data the MHRA (Medicines and Healthcare products Regulatory Agency) will walk blindly and feed the British public false information.
News this week that GlaxoSmithKline knowingly withheld clinical trial data from the MHRA regarding the top selling anti-depressant drug Seroxat will add further fuel to the fire and hopefully push for an independent review into how the MHRA could be duped into believing that a drug they have reviewed on numerous occasions was safe.
The MHRA are made up of medical experts, some of whom are former employees and shareholders of the pharmaceutical companies they grant licenses to. Surely this is wrong and at the very least there is the suspicion of a conflict of interest?
For too long now the MHRA have been hoodwinked by the Pharmaceutical Industry. Lawsuits for damages in respect of harm caused to patients are popping up all over the place, but avoid media and public scrutiny because they are usually settled out of court on the proviso that evidence is not made public.
A public enquiry is needed to examine how the MHRA is run and why former Pharmaceutical Industry directors are allowed onto the board. Would a convicted drink driver be allowed to adjudicate on a road safety panel?
The MHRA need to pull the plug NOW on their close associations with the Pharmaceutical Industry. The British public expects and naively assumes impartiality and not a regulatory authority whose main interest seems to be one of ‘delivering jobs for the boys.’
Mr Robert Fiddaman (Group Moderator of the Online Seroxat Support Group)
Birmingham, UK
Posted by: ROBERT FIDDAMAN | April 05, 2006 at 05:12 AM