Morning-After Pill:
Politics and the F.D.A.
By GARDINER HARRIS,
NYTimes on the Web, August 28, 2005
WASHINGTON, Aug. 27 -- For
more than a year, federal drug officials have insisted that their repeated
delays in deciding whether to approve over-the-counter sales of a morning-after
contraceptive have nothing to do with abortion politics.
Among veterans of the battles over drug approvals here, it is hard to find
anyone who believes them.
On Friday, the food and drug commissioner, Lester M. Crawford, announced that he
would indefinitely postpone a ruling on Plan B, the morning-after pill made by
Barr Laboratories. He explained that while the science supported
over-the-counter access for women 17 and older, the agency had not figured out
how to do that without younger teenagers getting the pills.
While the announcement prompted familiar responses on each side of the abortion
debate -- protest from abortion rights groups, support from abortion opponents
-- other veterans of the drug wars sounded more exasperated than anything else.
"At some point, the statute requires that the agency make a decision," said Dr.
Eve E. Slater, an assistant secretary of health from 2001 to 2003. "You
can't just delay forever."
The Plan B decision has become "overly politicized, and it shouldn't be," Dr.
Slater added. Under federal regulations, the Food and Drug Administration
was required to reach a decision on Plan B by January. Nothing happened.
Indeed, Barr executives said they had no discussions with the agency after
January. Usually when the agency is actively considering an application,
there is a constant back-and-forth with the company.
As the months passed, two Democratic senators who support abortion rights,
Hillary Rodham Clinton of New York and Patty Murray of Washington, vowed to
block any vote on President Bush's nomination of Dr. Crawford to become agency
commissioner unless the F.D.A. made a decision on the pill, for or against.
Mr. Bush has long been aligned with abortion opponents.
The senators relented in July after the secretary of health and human services,
Michael O. Leavitt, promised that a decision would be made by Sept. 1. On
Friday, both senators attributed Dr. Crawford's latest announcement to political
interference.
Dr. Robert Fenichel, a former deputy division director for cardiovascular and
renal drugs who left the F.D.A. in 2000, agreed, saying the agency's decisions
on Plan B were being driven by abortion politics.
"I've never seen anything like this before," Dr. Fenichel said.
That the Plan B fight is politically charged is nothing new, of course.
During Dr. Crawford's confirmation hearings, Senator Orrin G. Hatch, Republican
of Utah and a supporter of Dr. Crawford, called it not "a pharmaceutical issue
as much as it's a social issue."
Nor is it new that politics would play an important role in the decisions of the
F.D.A. or any other politically appointed regulatory agency. Elliott
Millenson, former president and chief executive of Direct Access Diagnostics, a
company that sought to sell an at-home test for H.I.V. infection in the 1980's
and 90's, recalled that when gay rights groups opposed the test, the agency
initially refused even to accept the company's application. "The
commissioner's office explicitly told us in 1992 that if we wanted approval we
would need to get political support for our product," Mr. Millenson said.
He sued the agency and won. The agency eventually approved the test,
although for business reasons the company never sold any.
"On sensitive issues, politics are business as usual at the F.D.A.," Mr.
Millenson said.
The agency approved Plan B as a prescription contraceptive in July 1999.
The pill provides a concentrated dose of the medicines available in most daily
birth control pills; it can prevent pregnancy if taken as long as 72 hours after
intercourse. Many abortion opponents view it as tantamount to abortion.
The F.D.A.'s announcement on Friday led to open bickering between abortion
rights advocates and Barr executives. Publicly, the two sides have been
supportive of each other for nearly two years, but privately, they have long
disagreed on strategy.
In May 2004, the food and drug agency rejected Barr's application to sell its
drug over the counter, saying the company had failed to provide enough
information about how well girls younger than 16 understood the drug's label and
whether they might engage in riskier sex if the drug was easily available.
At that point, Barr had two choices. It could have undertaken another
"label-comprehension" study with scores of young teenagers and then resubmitted
an almost identical application. Or it could have used the data that it
had on hand and reapplied to sell the drug as an over-the-counter pill only to
women 16 years of age and older. Younger girls would have to get a
prescription. On Friday, the agency changed the age to 17.
Kirsten Moore, president of the Reproductive Health Technologies Project, an
abortion rights advocacy group here, said she and fellow advocates suggested
that Barr do another label study. Barr decided to reapply with existing
data. No one knows whether the advocates' strategy would have worked, but
Barr's has not, at least so far.
Ms. Moore said label-comprehension studies were relatively easy, cheap and quick
to perform. Most are done in malls, where researchers set up a table and
ask passers-by to read a drug label and answer a few questions.
Bruce Downey, Barr's chairman and chief executive, said he did not regret the
company's actions. And Dr. Carol Ben-Maimon, chief of Barr's proprietary
research, said F.D.A. officials never told the company exactly what questions a
new study should answer.
In addition to label comprehension, the agency voiced concerns about Plan B's
effects on sexual promiscuity and sexually transmitted diseases, Dr. Ben-Maimon
said. To answer those questions, a quick study at a mall would not
suffice, she said.
Dr. Crawford said Friday that the F.D.A. would seek public comments over the
next 60 days on whether it had the authority to approve Barr's application and
whether it could enforce any regulation that would stop girls younger than 17
from buying the pill freely.
Ms. Moore said she and other abortion-rights advocates wanted Barr to withdraw
its present application, perform a label-comprehension study and then apply to
sell the drug over-the-counter to women of all ages. Rejecting the
application again if it contained clear data showing that young teenagers
understood how to use the drug would be more difficult for the agency to justify
with scientific or regulatory rationales, she said.
"It's time to call F.D.A.'s bluff," Ms. Moore added.
Mr. Downey, of Barr, said the company was considering a new label-comprehension
trial and added that it would provide comments to the F.D.A. during the next 60
days.
Whether the agency will listen to those comments is unclear.
"We volunteered repeatedly to put proposals forth to the F.D.A.," Dr. Ben-Maimon
said. "They didn't really seek out our opinions or thoughts on how we
could implement them."
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