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Heart of Bureaucratic Darkness

Government ineptitude is usually a punch line, but the dark reality is that bureaucratic malfeasance can carry a body count. The Food and Drug Administration is months late deciding whether to approve a drug for muscular dystrophy, and by now there’s only one explanation: Some of the agency’s staff have exploited FDA processes to evade accountability for an unprofessional review.

Ten of 12 boys with Duchenne muscular dystrophy walk after four years of treatment on eteplirsen, which produces the protein dystrophin. FDA has pushed off approval for the first-in-class treatment, asking for more time or even months-long delays blamed on snow. In June FDA asked the drug’s sponsor, Sarepta Therapeutics, SRPT 0.45 % for readouts from a continuing trial, which the company said it would provide shortly. Since then, radio silence from the FDA.

It’s no secret that the drug’s detractors are career employees in the neurology division, two of whom opposed approval at a public FDA meeting in April: Eric Bastings, deputy director of the division; and Ronald Farkas, a clinical team leader. The pair say the drug doesn’t produce “enough” dystrophin, or maybe any dystrophin, depending on which day you ask. Janet Woodcock, head of the drug evaluation center, can overrule the department and the recommendations of an advisory panel.

The question is whether someone in the division is holding up an approval by Dr. Woodcock with what is known as a differing-professional-opinions proceeding, which is an agency process for handling scientific...


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