Risk-management plans (RMPs) are being used too frequently and could impede the supply of medical care, according to Scott Gottlieb, deputy commissioner for medical and scientific affairs at the US Food and Drug Administration.
And his concern is that the FDA is being pressured into increased use of RMPs by external influences, even though the FDA in fact does not have the legal authority to impose these plans on drug sponsors.
RMPs – which can include a diverse range of safeguards such as the setting up of named-patient registries, physician training and regular patient monitoring – are being used more and more often for new drugs whose safety is still a concern, despite efficacy that justifies approval. But the burden of implanting these plans may make some hard-pressed clinics reluctant to offer the new therapies, and some patients may find it impossible to get access to new drugs because they live too distant from a doctor cleared to prescribe the drug.
There are some cases where the use of RMPs are justified, such as the controls placed on the use of Celgene’s thalidomide when it returned to market as a cancer drug, decades after being taken off the market after causing severe congenital abnormalities when used to manage morning sickness in the 1960s.
RMPs are proliferating, said Gottlieb, and in some cases are a ‘less-than-optimal response to more systemic systems problems in the delivery of medical care’.
And the consequence could be burdensome for physicians and patients, he said in a speech delivered to the American Medical Association on June 12. While those implemented to date have been careful to respect medical practice issues, “I worry about the future,” said Gottlieb.
The issue “tugs at where the boundary is between our role at FDA and the role of practicing doctors,” said Gottlieb, noting that the agency is sometimes put under pressure to step across it by some groups and political bodies.
The full text of Gottlieb’s speech is available here.