Andrew von eschenbach proved his worth this past summer by extricating FDA from the highly politicized debate over broader
access to the morning-after pill, Plan B. Delay in approving an over-the-counter (OTC) version of the drug had undermined
the agency's golden reputation for adhering to high scientific standards in determining drug safety and efficacy; the quagmire
also put von Eschenbach's nomination to head the agency on hold for months.
Advocates for emergency contraception still want the drug available without a prescription to anyone who wants it, and opponents
continue to attack it as dangerous and likely to spur teenage sex. Nonetheless, the final decision seems a workable compromise.
FDA provided sufficient explanation for its requirements: an age-18 cut-off, pharmacy-only distribution, and common packaging
and labeling for both OTC and prescription products. And Barr Pharmaceuticals met the criteria.
The road to approval began in July when von Eschenbach decided that the agency did not need new rulemaking in order to address
the drug's unusual regulatory status. That set the stage for Barr to craft an educational and distribution plan to fit FDA's
parameters. Pharmacists applauded the behind-the-counter status of the product, and FDA hinted that its lengthy deliberations
on Plan B may pave the way to more pharmacy-only OTC products. The Center for Reproductive Rights said it would continue its
lawsuit against FDA, claiming that its compromise does not ensure sufficient access to Plan B. Conservatives voiced opposition
to FDA's action, but President Bush had already signaled support for "Andy's decision" on the dual status of Plan B.
Barr says Plan B won't be a big money-maker with a fat promotion budget, because patients use the drug occasionally—instead
of chronically, like other contraceptives. Even if sales triple from a current $30 million, as some analysts project, that
won't be enough to greatly expand its current $1 million budget for consumer magazine and professional advertising or to support
DTC broadcast advertising.
Moreover, Barr has agreed to hold off on consumer promotion for six months after Plan B's OTC launch later this year. It will
first educate healthcare professionals through its sales force, continuing education programs, and professional advertising.
Any consumer ads will be submitted to FDA for review and targeted to an over-17 audience, with "language and visuals appropriate"
to an 18-44 age group.
All parties will be watching closely to see how this restricted distribution plan works. Barr will monitor Plan B sales to
ensure that pharmacists comply with its rules and to watch for emerging safety and efficacy issues. Such monitoring may pay
off if the data Barr collects supports expanded OTC access for teens by documenting that younger women can use Plan B responsibly.
The battle over Plan B now moves to the states. Before FDA's approval decision, the drug was available without prescription
through state pharmacy-action programs in nine states, including California, Maine, Massachusetts, and Washington. At the
same time, a few states have adopted legislation that allows pharmacists to refuse to fill certain prescriptions, such as
emergency contraception. Advocates for the morning-after pill hope that FDA's approval decision will defuse local opposition
and prompt most pharmacists to fill prescriptions.
It might be easier to monitor Plan B dispensing and post-approval safety under the fully electronic drug information system
that FDA proposes to put in place. The agency has already established an e-labeling system linked to the DailyMed database
as a way to expand public access to drug information and to support electronic-prescribing initiatives.
Now the agency proposes an Electronic Drug Registration and Listing System that will hold data on every drug manufacturer
and the products they make. It will include US and foreign companies and list prescription and OTC products for humans and
animals, including vaccines and biotech therapeutics.
FDA has long maintained a listing of all drug products distributed in the United States with name of manufacturer, product
formulation, and National Drug Code (NDC) number, but the system is rife with errors and omissions. Many manufacturers fail
to accurately register new products, report changes, and remove discontinued drugs from the list.