Risk Evaluation & Mitigation Strategies

Jun/25/2008 04:07
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So what is REMS and how is it going to affect DTC and drug sales? Well here is a short primer on this new FDA legislation and word of warning “doctors don’t like it..in fact they hate it” ! At it’s best REMS is meant to protect patients but at it’s worst it scares the hell out of physicians and adds more paperwork to medical practices that already have too many paperwork.

FDAAA was signed into law on September 27, 2007. Title IX, Subtitle A of FDAAA created new FDC Act § 505-1, which authorizes FDA to require applicants submitting a marketing application for a prescription drug or biological product to submit and implement a REMS if the Agency
determines that such a mechanism is necessary to ensure that the benefits of the product outweigh its risks. Certain products approved prior to the effective date of FDAAA are, under FDAAA § 909(b)(1), deemed to have a REMS in effect “if there are in effect on the effective date of this Act
elements to assure safe use --

(A) required under [FDA’s accelerated approval restricted distribution regulations at 21 C.F.R. § 314.520 or § 601.42]; or

(B) otherwise agreed to by the applicant and the Secretary [of Health and Human Services] for such drug.” New FDC Act § 505-1(f)(3) states
that “elements to ensure safe use” include the following:

(A) health care providers who prescribe the drug have particular training or experience, or are specially certified (the opportunity to obtain
such training or certification with respect to the drug shall be available to any willing provider from a frontier area in a widely available training
or certification method (including an on-line course or via mail) as approved by the Secretary at reasonable cost to the provider)

(B) pharmacies, practitioners, or health care settings that dispense the drug are specially certified (the opportunity to obtain such certification shall be available to any willing provider from a frontier area)

(C) the drug be dispensed to patients only in certain health care settings, such as hospitals

(D) the drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as laboratory test results

(E) each patient using the drug be subject to certain monitoring; or

(F) each patient using the drug be enrolled in a registry.

Think this is bad? Take a look at the forms on the Revlimid site. These forms have to be filled out every-time a physician writes an Rx and have to be signed by the physician and the patient. Imagine getting a form that lists really nasty side effects when you are prescribed a drug ? Think most patients are going to head for the hills or trust their physicians ? Of course the physician is only indicating that she/he read the drug information it does nothing about data that may not have been communicated to the FDA or the physician. Lilly’s new blood thinner drug may get a REMS and if it does you can pretty much cut a big chunk out of sales projections if the research that I have seen is any indication of how physicians feel.

Is it a step in the right direction? It’s too early to tell but there has to be a better way to keep physicians and patients better informed about the risks of drugs.
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