Your friendly Pharmer came home from work this morning to a message from a Reuter’s reporter, asking for comment on this story. Lacking real information, there was not much to do but comment on the inappropriateness of medically uneducated people, making decisions on matters in that field, and give information on the liabilities of the drug, particularly in teens and adolescents. Naturally, the reporter garbled the message.
Naturally, Pharmer thinks that a judge has no business ruling on whether a drug should be considered safe enough for over the counter sales, (unless he would perhaps rule simply on whether the FDA should exist or not ;-) .
It appears that Judge Edward Korman of the Eastern NY division of the Federal court has made two decisions on this issue. One of them impinged on dropping the age to 17 to obtain Plan B One-Step without a prescription. The actual decision is HERE.
The 2nd and current decision, which resembles a temper tantrum in style, further loosens the restrictions, and has countermanded Kathleen Sebelius’ Dec. 2011 decision to limit over the counter sales to girls under 17 years of age. Now it appears that the FDA is ordered to allow general sale of Plan B One-Step over the counter within the next 30 days, “without point of sale or age restrictions”. Judge Edward Korman has made a pretty good argument for completely eliminating the FDA, since its decisions are moot, and may be overturned at any time by a medically uneducated Federal Judge.
So far, only Plan B (levonorgestrel) is being addressed in this decision. Ella is excluded from consideration. Korman’s one-man usurpation of FDA regulatory functions cedes only the label requirements and the ability to regulate the sale of of the older 2-pill version, Plan B, back to the agency.
The FDA will have to generate mega-reams of paperwork to address these and other momentous decisions, such as whether to re-categorize hydrocodone as a CII controlled substance. They have minutiae to manage, and certainly will not have time to appropriately address the rampant and unprecedented drug shortages which are causing medical errors and deaths in our hospitals and communities.