Physician's Integrity Group Sues FDA Over Roflumilast

Physicians for Integrity in Medical Research (PFMIR) has sued the Food and Drug Administration (FDA) over roflumilast for chronic obstructive pulmonary disease (COPD). The physician’s group alleged in a federal complaint, addressed to FDA commissioner Margaret Hamburg, that the drug’s downsides outweigh the benefits, it does not work as intended, and serious side effects have occurred.

Roflumilast

On Feb. 28, 2011, the FDA approved roflumilast (brand name Daliresp) to treat COPD and issued a press release detailing the drug’s profile. Marketed by St. Louis-based Forest Pharmaceuticals, a subsidiary of Forest Laboratories, roflumilast was approved for daily dosage to decrease flare-ups and symptoms from severe COPD. COPD makes breathing difficult due to severe lung disease. Cigarette smoking is the main cause of the condition and COPD is in the top five leading causes of death in the U.S. Curtis Rosebraugh, M.D., M.P.H., of the FDA said, “COPD is a serious disease that gets worse over time.”

Roflumilast inhibits the phosphodiesterase type 4 (PDE-4) enzyme, decreasing cough symptoms and mucus. The drug is not intended for emphysema COPD. Roflumilast’s effectiveness and safety was demonstrated in clinical studies with over 1,500 participants, and proved convincing enough for FDA approval.

Physician Petitions and Court Actions   

PFMIR sent a petition to the FDA requesting that the drug be withdrawn from the market. The FDA rejected the complaint late in 2012, stating that the drug was approved for a specific use, that the risk-benefits ratio was positive, and COPD patients benefit from the drug. The physician’s group responded in the newly filed lawsuit that the risk/benefit ratio was not positive. Additionally, the group points out the numbers of patients on the drug who have developed prostrate and lung cancer. Physicians said that patients showed an increase in suicides, weight loss, gastroenteritis, and pancreatitis.

The physician’s group asks the federal court to revoke the FDA’s approval of roflumilast. The Federal Tort Claims Act is the statute that may govern and limit the lawsuit. In the Act, the United States authorizes or denies lawsuits against itself and its employees. The FDA may invoke “sovereign immunity,” denying anyone the right to sue the agency for approved drugs that later prove defective.