Judge Cites “Strong Showing of Bad Faith” by Government as Grounds for Granting Further Discovery
U.S. Magistrate Judge Viktor Pohorelsky ruled that the Centre pour les droits reproductifs can subpoena White House documents as part of its lawsuit against the Food and Drug Administration for its failure to make Plan B available without a prescription for women of all ages. Concluding on November 6 that the Center demonstrated a “strong showing of bad faith” by the FDA in its decision-making around Plan B, Judge Pohorelsky also rejected the government’s request to block the deposition of former White House policy aide Jay Lefkowitz, and granted the Center’s request to depose deputy director of the FDA’s Office of New Drugs, Dr. Sandra Kweder.
The Center will subpoena the White House for the following documents: communications between the Domestic Policy Office of the White House and select employees of the FDA regarding Plan B between April 2003 and September 2006.
“We are pleased that the court is not only allowing us to further explore seemingly inappropriate White House involvement in the FDA’s decision making, but is also recognizing that our claims of the agency’s bad faith are well founded,” said Nancy Northup, President of the Centre pour les droits reproductifs. “Our months of discovery have revealed that FDA scientists attempted to carry out a scientific approval process, but higher level officials made a mockery of that process, by ignoring the results and bowing to political pressures.”
In his ruling, Judge Pohorelsky found “five categories of information to be reflective of improper FDA behavior:
1) Involvement in the Plan B OTC-approval process by high-level FDA officials who, historically and statutorily, do not generally participate in OTC-switch proceedings,
2) Inappropriate (non-scientific) considerations by FDA officials imported into the Plan B OTC-switch process, including those brought to the FDA’s attention by third parties,
3) Indications of efforts to chart an unusual course in dealing with the OTC-switch applications, including veiled attempts to delay reaching a final decision, 4) Indications that a decision had already been made or that efforts were made to steer the application towards a specific result under the direction of higher level officials before completion of the scientific process,
5) Indications of potential retaliation by upper management against FDA employees who disagree with management’s views that Plan B OTC-access be restricted.”
On August 23, the FDA announced its decision to make Plan B available without a prescription, but only for women 18 and older and only behind the pharmacy counter. The Centre pour les droits reproductifs is still pursuing its lawsuit to ensure that the Plan B is granted true over-the-counter status and made widely available to women of all ages, particularly the most vulnerable population, young women.
In 2001, the Center filed suit against the FDA in the U.S. District Court for the Eastern District of New York. The suit was filed on behalf of the Association of Reproductive Health Professionals (ARHP), National Latina Institute for Reproductive Health, and individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy.