Friday, December 9, 2011
Antibiotics and Contraceptives
The big news this week was that Kathleen Sibelius, Secretary of the Department of Health and Human Services, overruled Commissioner of FDA Margaret Hamburg on the over the counter sales of a morning after contraceptive (Plan B). That a Secretary of HHS would overrule an FDA Commissioner is unprecedented. Her rationale was that the generics company that made the proposal, Teva, had not studied the drug for safety in children age 11. Of course, the fact that no other over the counter drug had ever been required to carry out such a study did not enter into the equation. Neither did the careful scientific review carried out by the FDA which included at least two studies of young teenagers. Not only that – but President Obama supported the decision of his HHS Secretary overruling his FDA Commissioner.
What does this have to do with antibiotics? Antibiotic resistance contributes directly to the deaths of about 70,000 Americans per year. The Infectious Diseases Society of America estimates that the additional cost of antibiotic-resistant hospital infections alone ranges from $21-34 BILLION per year. While there are many causes for this increase resistance including unnecessary or inappropriate use of antibiotics, most experts agree that we will need to continue to bring new antibiotics to the market to combat a continuing onslaught of resistant bacteria. In this regard, the FDA has been a major roadblock to progress. They continue to approve fewer and fewer new antibiotics as shown here. Of course, the lack of approvals is not entirely the fault of the FDA. Some antibiotics brought to them should not have been approved. But clearly FDA policies and recent guidance documents requiring infeasible trial designs have been major contributors to our depleted antibiotic pipeline. While I believe that FDA now recognizes the error of its ways in promulgating requirements for infeasible trial designs for antibiotic development, they are correcting their errors slooooooooowly. At the same time they are starting to rethink current feasible guidance documents for development of drugs for urinary tract and intra-abdominal infections. Scary!
Earlier this year I wrote an open letter on this very topic to Secretary Sibelius on this blog. I am sad to say that I got no response. It is clear to me that contraceptive use and sex are fields with popular “interest,” lobbyists and money. It is an election year. Antibiotics is not sexy, has precious little in the way of lobbyists and certainly doesn’t have any money since most of the large pharmaceutical companies have abandoned the area entirely. So I guess that neither President Obama nor Secretary Sibelius will be interfering with the FDA’s bumbling response to our desperate need for a full and healthy antibiotic pipeline. . . . .