The FDA and Big Pharma are in strong talks to decide how much drug companies will pay the agency to review new drugs from the end of next year, when the current law expires.
Last week, the FDA's deputy commissioner Scott Gottlieb said that pharma companies should contribute additional funds so the agency can study the drugs' safety once they reach the market.
The US drug industry is now negotiating the fourth version of the Prescription Drug User Fee Act (PDUFA) with the regulator – the outcome could change radically the landscape for pharma companies.
Until now, user fees paid by firms have primarily been used to review the safety and efficacy of new drugs before they are approved to be sold on the market.
However, during a speech at the Manhattan Institute last week, Gottlieb recommended to increase fees in order to hire extra staff to monitor pharmaceuticals once they are marketed.
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Last week, the FDA's deputy commissioner Scott Gottlieb said that pharma companies should contribute additional funds so the agency can study the drugs' safety once they reach the market.
The US drug industry is now negotiating the fourth version of the Prescription Drug User Fee Act (PDUFA) with the regulator – the outcome could change radically the landscape for pharma companies.
Until now, user fees paid by firms have primarily been used to review the safety and efficacy of new drugs before they are approved to be sold on the market.
However, during a speech at the Manhattan Institute last week, Gottlieb recommended to increase fees in order to hire extra staff to monitor pharmaceuticals once they are marketed.
More
Pharma Marketing Blog seems to have the inside track on what's going on with DTC!
1 comment:
The FDA ahould look for a solution to this issue, up north to Canada. Not to HPB ( Canadian FDA) but to big pharma companies, the sisters and brothers of the ones in USA. This only if following type of Post Marketing Surveilance trials, have not beed done in USA too. In that case the solution is right at home:
Here is the deal that has gone for couple of dacades in Canada.
PMST is designed and carried out by a big pharma Co. year or so after the intro. At that time the novelty factor is gone and they need to boost the sale. The "trial" is designed in such a way, that very large numbers of doctors and patients (in thousands) are inrolled, usually GP's in very simple manner. All thye have to do supply the Co with patients initials and basic med. profile. Enrole the patient in the "trial" by giving him/her prescription for which the patients pay ( this is the key for sales increase) the doctor gets a fee for just Rxing the drug, very little if any paper work (they hate that the, docs). The "outcome" of the trial is compilled by either the big pharma Co or what is more common lately this is outsourced to a third non-pharma party. The results and "trial" are never published, for the whole thing was just a front to increase sales of "investigated" drug. These "trials" are of course illegal but they find the way to cover it up. This insider has seen the company's own regulations that do not permit trials in which the patient has to pay for the drug. This is not permitted by any of the rules regulating the ethical issues of doing trial either. But hey, they are the big pharma. Who can regulate them or stop them?
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