Postpartum Depression Bill Likely to Move Forward

Democratic control of Congress may result in the dislodging of a long-stuck bill authorizing an unspecified amount of additional federal funding for research into postpartum depression. But in hearings in a House subcommittee recently, Republicans voiced an intention to add postabortion depression to the bill's focus.

Rep Bobby Rush (D, Ill) introduced the Melanie Blocker-Stokes Postpartum Depression Research and Care Act (HR 20) 6 years ago after learning about the woman for whom the bill is named. She jumped out of a 12th floor window of a Chicago building in June 2001 after giving birth to a daughter and after multiple psychiatric hospitalizations in the wake of that birth.

The bill, which has 120-plus co-sponsors, including the top Republican on the House Energy and Commerce Subcommittee on Health to which it was referred, directs the NIMH to "expand and intensify" research and related activities on postpartum depression and postpartum psychosis and directs the Secretary of Health and Human Services (HHS) to make grants to establish, operate, and coordinate effective and cost-effective systems for the delivery of essential services to individuals with such conditions and their families.

But at May hearings at the House health subcommittee, Rep Nathan Deal (R, Ga), the top GOP member of the subcommittee and a cosponsor of the bill, argued for inclusion of research and treatment for postabortion depression based in part on testimony that day from Michaelene Fredenburg, president of a group called Life Perspectives. She spoke about how, after having an abortion at age 18, she experienced an intense negative emotional reaction. "My emotional reaction lasted for several years and included an eating disorder, depression, intense anger, profound sadness, loss of appetite, fatigue, and suicidal ideation," she stated.

Cathy Roca, MD, chief of women's programs at NIMH, said in an interview with Psychiatric Times that NIMH already includes postabortion depression in the list of topics designated as potential research targets by its program for women's mental health in pregnancy and the postpartum period, which has a budget of about $14.5 million this fiscal year. Roca added that NIMH funds additional research in the postpartum depression area via grants for bipolar disorder and major depression, which touch on women's postbirth issues.

Rep Frank Pallone (D, NJ), chairman of the House health subcommittee, has promised a vote on the Rush bill, according to Rush spokesman Toure Muhammad.

House Seeks to Strengthen Drug Surveillance Reforms

The House will probably upgrade the drug safety reforms bill that the Senate passed on May 9 when it voted 93 to 1 to approve renewal of the Prescription Drug Users Fee Act (PDUFA). That bill included a drug safety amendment called the FDA Revitalization Act, sponsored by Sen Edward Kennedy (D, Mass).

Kennedy's amendment is a response to safety problems discovered after drugs such as Vioxx and SSRI antidepressants were on the market for substantial periods. Critics have said the FDA responded much too slowly to reports of safety issues in both instances, a criticism that was heard again recently based on a report aboutthe increased risk of severe cardiac problems attributable to the diabetes drug rosiglitazone (Avandia).

"It is incredible that the agency charged with protecting the public health has such a poor record when it comes to postmarket drug safety," said Rep John Dingell (D, Mich), chairman of the House Committee on Energy and Commerce, where the PDUFA bill has been referred.

"Regrettably, it is incidents like this [Avandia] that demand legislative changes in the way FDA deals with drug safety. The committee will address these dangerous shortcomings while writing legislation to reauthorize PDUFA."

Dingell may try to strengthen some of the Kennedy postmarketing reforms, which did not go far enough for some of the FDA critics in the Senate, who ended up voting for the PDUFA bill when their safety improvements to the Kennedy bill failed.

Kennedy's amendment does 2 things. First, it allows the FDA to order drug companies to prepareRisk Evaluation and Mitigation Strategies for new drugs. These could include requirements that the company perform postmarketing studies or clinical trials. The FDA currently does not have the authority to mandate those studies. When the Kennedy bill came to the Senate floor, Sen Charles Grassley (R, Iowa), who argued that it was too tame, offered an amendment to increase from $10,000 to $250,000 the maximum civil fine for failure to meet a study deadline, with the amount of the penalty doubling every 30 days up to a total of $2 million instead of the $1 million ceiling in Kennedy's bill. Grassley's amendment passed easily.

However, Grassley failed by a narrow vote of 46 to 47 to establish a separate safety office within the FDA's Center for Drug Evaluation and Research that would have equal standing to the Office of New Drugs. Currently, postmarketing surveillance is the responsibility of the Office of Surveillance and Epidemiology, which is subordinate to the Office of New Drugs.

Kennedy's amendment also authorizes a public-private partnership to establish a "routine active monitoring system," which would create a pool of relevant data assembled from federal and private electronic health care population databases. This apparently would be a complement to—or even rival—MedWatch, the FDA's current adverse effects early warning system, which is based on reports from physicians, patients, hospitals, and others. But MedWatch's data collection is very spotty. According to the Kennedy bill, the data pool would have to include data on 25 million patients by January 1, 2009, and 100 million by January 1, 2012.