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60-day Comment Period on Plan OTC Ends

On Tuesday, November 1st, the FDA's 60 day comment period on making Plan B emergency contraception available over the counter ended with little fanfare or comment from the FDA. The RMC joined four dozen other medical and choice organizations on October 4th in submitting official comments to the FDA urging them to abandon the rulemaking process and outlining why it is unnecessary. The FDA began the rulemaking this August, again avoiding making a decision on the Plan B application that has languished at the agency for 2 years.



The FDA will now review the tens of thousands of comments received and, if they continue with the process, they will then write a draft rule. This draft rule for how Plan B should be labeled and sold will then be reviewed by the FDA, the Department of Health and Human Services and the White House Office of Management of Budget. Once approved by all three, it will be published for yet another public comment period to begin the process again. Ultimately, this rulemaking could delay the process indefinitely.



Congressman Christopher Shays (CT-2) was part of a bi-partisan group who introduced legislation requiring a decision on Plan B in response to the FDA's delay. Shays stated, "The FDA has failed to take action on approving Plan B for over-the-counter status, despite scientific data that shows it would be safe." He continued, "The FDA should make decisions based on science, not politics and ideology. The bottom line is, expanded access to emergency contraception will safely decrease the risk of unintended pregnancy and decrease the number of abortions."



Vote on Stem Cell Research in the Senate Pushed Back

Faced with a busy fall of hurricane relief, Appropriations bills and Supreme Court nominations, the Senate will not take up the Stem Cell Research and Enhancement Act until after the winter recess. Senator Arlen Specter, the lead on the bill, discussed adding the measure as an amendment to a health spending bill but decided to drop the threat saying it could cause a "multi-faceted controversy".



Senator Specter had been joined by an array of Democrats and fellow Republicans in calling for a vote, but ultimately concluded the bill would get greater recognition in holding off until after the winter recess.