FDA Allows Companies to Skip Import Bans: Report

A ProPublica investigative report cites at least 20 instances in which FDA identified significant problems at drug manufacturing firms in India, imposed import bans on the firm’s products, and then secretly allowed the companies to continue to ship drugs to the U.S. Focusing initially on Sun Pharma, the report says that after agency inspectors found issues that were so egregious it banned a Sun facility from exporting drugs to the U.S., “a secretive group inside FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the U.S. even though they were made at the same substandard factory that the agency had officially sanctioned. Pills and injectable medications that otherwise would have been banned went to unsuspecting patients across the country, including those with cancer and epilepsy.”

ProPublica says FDA did not test the imported drugs for quality problems or track them to see if patients were adversely affected. And, it says, it kept the exemptions largely hidden from the public and Congress.

“We felt we didn’t have to make it a public thing,” former CDER director, acting commissioner, and principal deputy commissioner Janet Woodcock told the investigative reporting organization.

The report says ProPublica found that over more than 10 years, “the same small cadre at FDA granted similar exemptions to more than 20 other factories that had violated critical standards for drug-making, nearly all in India. All told, the group allowed into the United States at least 150 medications or their ingredients from factories with mold, foul water, dirty labs, or fraudulent testing protocols.”

Woodcock said she supported the exemptions as a “practical approach” to avoid drug shortages. “We had to kind of deal with the hand we were dealt,” she said.

She said she didn’t see a need to inform the public because the agency believed that the drugs were safe. Former FDA commissioner Robert Califf told ProPublica that tough calls had to be made and the practice did not worry him.

The report says some of the drugs were recalled, just before or just after they were exempted, because of contaminants or other defects that could cause health problems. A ProPublica analysis identified more than 600 complaints to FDA about exempted drugs at just three of the 20 factories. It says adverse event reports on affected drugs from Sun Pharma and Intas Pharmaceuticals cited about 70 hospitalizations and nine deaths.

The report says FDA did not respond to questions about who made the decisions or how the drugs were evaluated, and declined requests for interviews with officials who are currently overseeing drug regulation. An email said exemptions are “thoroughly evaluated through a multi-disciplinary approach.”