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The tenure of Dr. Lester M. Crawford as FDA Commissioner was a short one, with his resignation in September coming less than three months after his confirmation.

Dr. Crawford’s stay at the FDA as deputy commissioner, acting commissioner, and then as commissioner was never without controversy and his critics inside the agency, in Congress, and among consumer advocates often accused him of making decisions based on political considerations and not on medical or scientific grounds.

The inordinate (three-year) delay in acting on Barr Laboratories’ application to approve the over-the-counter (OTC) sale of the emergency contraceptive Plan B was seen by many as being driven by politics, although Dr. Crawford maintained his actions were motivated solely by scientific and legal considerations.
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The FDA has announced the approval of “a biologics license application (BLA) for Myozyme (alglucosidase alfa, rhGAA), the first treatment for patients with Pompe disease, a rare but severely debilitating disease. Pompe disease, which affects one in 40,000-300,000 individuals, drastically reduces a person’s muscle and respiratory function.”

Myozyme had been granted FDA “Orphan Drug” designation and was approved under a priority review. Myozyme is manufactured by Genzyme Corp. in Cambridge, Massachusetts.

So-called “orphan” products are developed to treat rare diseases or conditions that affect fewer than 200,000 people in the U.S.
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A review of records for the past 10 years indicates that the Consumer Product Safety Commission (CPSC) has announced eight recalls for various types of TV tables or TV stands that had the potential of allowing an unstable television to fall onto children thereby causing serious injuries or death.

Eight recalls between 1995 and 2006 for over 3 million such products contained reports of everything from relatively minor injuries to fractured skulls and deaths to young children as the result of being crushed under falling television sets.
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