Healthy Skepticism Library item: 18616

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Publication type: Electronic Source

Herper M
The FDA's New Power
Forbes Blog 2010 Aug 20
http://blogs.forbes.com/matthewherper/2010/08/20/the-fdas-new-power/

Full text:

The Food and Drug Administration warned in 1999 that combining the cholesterol drugs Baycol and Lopid increased the risk of deadly muscle side effects. But the warning had no effect. The percentage of Baycol patients who got Lopid, too, dropped from 63% to 62%. Baycol was removed from the market in 2001.

It used to be gospel among drug safety experts that once a medicine was approved, there was nothing the FDA could do to limit its use. Even blaring warnings didn’t work. This was a key argument in keeping Merck’s painkiller Vioxx off the market. Sure, critics said, it might benefit some people who had a low risk of heart attacks and a high risk of stomach bleeding. But how would you make sure people at risk of heart problems never took it?

But in 2007, Congress passed a law dramatically expanding the FDA’s ability to put in place bureaucratic measures, quizzes, and other roadblocks in order to make sure patients are aware of any risks and that misuse is avoided. This has changed the FDA’s power in a fundamental way. Where once the agency’s palette was black-and-white, it now contains shades of gray. If GlaxoSmithKline’s diabetes drug Avandia stays on the market where Vioxx did not, it will probably be because the FDA feels it can restrict Avandia’s use using these new systems.

These safeguards, known as Risk Evaluation and Mitigation Strategies (REMS) were originally developed for drugs that cause birth defects, like Roche’s acne medicine Accutane or Celgene’s cancer pill Thalomid, also known as thalidomide. But now they have become the new hurdle for companies hoping to market medicines.

The need to fine-tune a REMS has become one of the most common reasons for a new drug to be delayed. Amgen’s most new osteoporosis medicine, Prolia, was rejected in October 2009 partly because of the need for a REMS; it is now approved. Stelara, a psoriasis medication submitted by Johnson & Johnson in 2007, was initially rejected because the FDA wanted J&J to submit a REMS; it was approved last year. Recently, an FDA panel voted that opoid-based drugs would need an even stricter REMS.

Developing REMS also resulted in delays for Vibativ, from Theravance, a much-needed hospital antibiotic that also carries a significant risk of causing birth defects if given to pregnant women; and for Sabril from Lundbeck, a treatment for a rare and deadly form of child epilepsy that had one of the longest drug reviews on record. (see: A Long And Deadly Wait)

For many new drugs, the REMS, not the traditional review of safety and efficacy, may be the most important hurdle. This morning, a panel of FDA experts is reviewing Rekinla, from Jazz Pharmaceuticals, as a treatment for fibromyalgia, a type of chronic pain. It is a version of GHB, a sedative that can be abused and has been used in date rapes. You might think that is controversial, but it’s not. FDA reviewers backed Rekinla’s effectiveness, and the drug is already sold for narcolepsy under the brand name Xyrem. But the reviewers are worried the REMS doesn’t do enough to prevent patients from accidentally getting both Xyrem and Rekinla, resulting in an overdose. Analysts at Concept Capital expect this to result in a rejection now, and approval once the REMS is worked out.

Obesity drug maker Arena Pharmaceuticals might also face a REMS problem when its lorcaserin goes before an FDA panel on Sept. 16. Another obesity drug, Qnexa from Vivus Pharmaceuticals, ran into trouble because an FDA panel wanted its REMS to be even more restrictive than it was. Arena has not developed a REMS for lorcaserin, but the panel might feel it has reasons for wanting lorcaserin’s use restricted. Lorcaserin is a much safer way of hitting one of the receptors tripped by fenfluramine, a diet drug that was pulled from the market for causing heart valve problems. But fenfluramine’s side effects may have happened when it was combined with another drug, phentermine. Panelists might want to nix a similar combo before approving lorcaserin, and that could mean a REMS.