McClellan’s new job stirs political controversy
pharmafile | March 2, 2004 | News story | |Â Â Â
The head of the FDA Mark McClellan is to quit his post in order to lead the reform of the country's healthcare insurance schemes Medicare and Medicaid.
Appointed by President Bush to head the FDA just 18 months ago, Dr McClellan has now taken up the administration's offer to head up the Medicare and Medicaid Services at the Department of Health and Human Services.
The departure is a blow for the FDA, which had suffered from a lack of direction in the period of nearly two years in which it lacked a permanent head before the arrival of Dr McClellan. The medic and health economist very quickly made his mark at the world's most important medicines regulations agency, introducing a broad range of initiatives to improve the speed and efficiency of its work.
Carl Feldbaum, president of the US biotechnology industry organisation (BIO) commented on the news: "Commissioner McClellan wasted no time in setting a new course for the FDA, one which is committed to new drug innovation by removing unnecessary regulatory barriers. The result has been a substantial number of approvals for a host of new medicines that will benefit millions of patients across the country."
"We wish Dr McClellan well on his appointment to head CMS [Centers for Medicare and Medicaid Services], the lead agency in implementing the new Medicare law. Based on the level-headed and streamlined approach that he has applied to his post at the FDA, we are optimistic that Dr McClellan will provide an equally high level of no-nonsense leadership to CMS.
The FDA's departing head received equally effusive praise from the country's generic manufacturers who praised his role in last year's reforms to accelerate generic access.
Despite the consensus between the two sides of the industry, Dr McClellan's appointment and one role in particular has generated serious criticism from the opposition Democrat party in the run-up to the country presidential elections in November.
Re-importation of medicines from Canada into the US became one of the hot topics of 2003, as increasing numbers of senior citizens burdened by high prescription drug costs travelled across the border for discount drugs, or used online pharmacies or wholesalers to ship them in.
As head of the FDA Dr McClellan has been one of the sternest critics of the practice, arguing that it jeopardised patient safety and was illegal, and led federal efforts to close down importers. He also stressed that the practice undermined pharma company earnings, claiming it could ultimately jeopardise the discovery and development of new medicines.
To the dismay of those who support re-importation, Dr McClellan will now lead an investigation into the pros and cons of the practice. The investigation is the result of a compromise in Congress over the issue to allow the Medicare bill to be passed, but critics say a McClellan-led report can only have one conclusion.
Senator Byron Dorgan says he is "astounded" at the choice of Dr McClellan.
"This is really unbelievable," he said. "Dr McClellan has clearly made up his mind not to allow re-importation and has done everything in his power to stop it. He has clearly already chosen to stand with the drug manufacturers who over-charge Americans for their medicines, and to work against the interest of the American people.
He concluded: "Why anyone would think even for a minute that this is an acceptable appointment is beyond me. It gives new meaning to putting the fox in charge of the chicken house".
The new Taskforce on Drug Importation has been charged with consulting with a range of stakeholders, including those for and against the practice, and Health Secretary Tommy Thompson pledged the review would be even-handed.
"It will hear from all sides of the issue in a public, transparent manner. I'm confident that it will produce a balanced picture of the costs and benefits of drug importation," he said.
Meanwhile, health charity the Kaiser Family Foundation has warned that Dr McClellan's main task of introducing the new Medicare system will be a difficult one. A survey conducted on behalf of the charity found most seniors were not aware the new legislation had been passed, and of those that had, the majority did not know the system very well and did not have a favourable impression of it.
Head of the Foundation Drew Altman said the lack of understanding of the new laws made them "ripe for political demagoguery on both sides" in the run up to the presidential elections.
"The President will say he delivered a good prescription drug law and Democratic candidates will say it's a bad law. How are seniors to judge?" He added: "Customised, one-on-one assistance to really give beneficiaries meaningful help" would be the only way most seniors could make the most of the new system.
The polticisation of the issue is such that Democrats have asked for the Justice Department to launch an investigation of a new advertising campaign promoting the new Medicare, which they have dubbed "re-election ads" for President Bush.
The advertising campaign entitled "Same Medicare. More Benefits" will run on TV, radio and print media and will be paid for out of the $1 billion budget earmarked for implementing the new system.
Meanwhile, Billy Tauzin, a congressman and chair of a committee with partial responsibility for Medicare has been forced to end discussions about becoming president and chief executive of US pharma lobbying organisation PhRMA. Despite insisting that the job offer was not a reward for promoting reforms favoured by the industry, Republican colleagues are said to have demanded he turn down the role.
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