Healthcare provider pushes back on FDA's REMS policies

Pharmaceutical CommercePharmaceutical Commerce - January/February 2010

Kaiser Permanente files a citizen’s petition to revise FDA’s process of imposing REMS programs; also objects to restrictions on wholesale-distribution

The way that Risk Evalution and Mitigation Strategies (REMS) has come to be imposed on drug distribution, manufacturers and FDA regulators sit down and hash out how rigorously a drugmaker will have to monitor product use and patient safety. The most extensive type of program, an ETASU (elements to assure safe use) can require registering patients, certifying prescribers, and working with restricted list of distributors.

Late last year, Kaiser Permanente (Oakland, CA), the massive California insurer and provider network, filed a citizen’s petition to revise FDA’s policies. It was responding to the proposed guidance that FDA issued last September, and, to some degree, the experiences it has already had in dealing with REMS requirements. It lists five objections:

1. to increase the transparency with which REMS decisions are made, and to include providers in the discussion

2. to make data collected by REMS programs publicly available

3. to routinely evaluate ETASU programs

4. to prevent manufacturers from using REMS requirements “to give preferential treatment to certain health care providers”

5. to ensure the confidentiality of protected health information (a HIPAA patient-privacy requirement) and ensure that only necessary information is collected.

Data availability, ongoing evaluations and patient confidentiality could be considered necessary refinements of how FDA is running the REMS programs. But the prospect of including providers in the REMS deliberations raises the prospect of limiting the scope of a REMS based on providers’ objecting to the amount of data and monitoring they would have to perform. Kaiser’s complaint notes that the law specified that REMS not be “unduly burdensome” on patient access, or toward healthcare delivery systems; it cites the ongoing discussion over a class-wide REMS for opioids as having “greater impact” on providers.

There’s a financial angle, too. Under some REMS, a restricted list of distributors (or an exclusive distributor) is specified, and these distributors are required to monitor the prescribers ordering a drug. But Kaiser notes that it has its own pharmacy network (which is linked to patients’ electronic health records--EHRs). With its 8.7 million covered lives and operating across nine states and the District of Columbia, it can act as its own specialty distributor/specialty pharmacy. The petition states that several manufacturers have used a REMS requirement (whether or not it contained an ETASU component) to force Kaiser to use a specific distributor—which is “plainly anticompetitive,” according to the complaint. And for Kaiser, which has one of the most advanced EHR systems in the nation, the need to work with outside pharmacies can interfere with its own ability to monitor patient conditions—which is one of the motivating forces behind REMS programs in the first place.

Kaiser notes that FDA is evolving its guidance on managing REMS programs. But there is a collision looming between what FDA is seeking from manufacturers as obligations, and what the providers are willing to comply with.

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