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Bipartisan E&C Leaders Request Information from FDA About Efforts to Stop the Importation of Illegal Opioids


06.11.18

WASHINGTON, DC – Bipartisan Energy and Commerce Committee leaders sent a letter to the Food and Drug Administration (FDA) on Friday regarding its Office of Criminal Investigations (OCI) and ongoing efforts to stop the importation of illegal opioids and other potentially harmful products coming through international mail facilities (IMFs).

The leaders wrote, “Your leadership in ensuring the integrity of these products at the nation’s ports of entry is appreciated and we support your efforts. We write today to request information about the implementation of your priorities at OCI.”

This week, the House will consider two bills pertaining to international mail facilities.

On Tuesday, the House is scheduled to consider H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now (SCREEN) Act, authored by Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ). H.R. 5228 will provide the FDA with stronger recall and destruction authority to disrupt the entry of counterfeit and illicit drugs through IMFs.

On Wednesday, the House is scheduled to consider H.R. 5752, the Stop Illicit Drug Importation Act of 2018, authored by #SubCommTech Chairman Blackburn (R-TN). H.R. 5752 will streamline and enhance FDA’s tools to intercept illegal products.

To read a copy of the letter, click HERE.

To learn more about Energy and Commerce’s comprehensive efforts to combat the opioid crisis, click HERE.

House panel questions FDA’s track record combating illegal opioids

U.S. lawmakers fear the Food and Drug Administration is not doing enough to stop the flow of illegal drugs into the United States as the country works to combat the opioid epidemic.

Republican and Democratic members on the House Energy and Commerce Committee questioned whether the FDA’s criminal investigators are effective at blocking illegal drugs at U.S. ports of entry, in a letter seen by Reuters.

“We have concerns about whether the FDA is appropriately devoting its resources to prioritize these efforts against unapproved opioids,” wrote the lawmakers, including the panel’s Republican Chairman Greg Walden and leading Democrat Frank Pallone, in a letter to FDA Commissioner Scott Gottlieb.

Lyndsay Meyer, a spokeswoman for the FDA, confirmed the agency had received the letter and plans to respond.

The FDA’s Office of Criminal Investigations (OCI) is responsible for launching criminal probes into counterfeit, adulterated and mislabeled and unapproved drugs.

It has been under scrutiny by the committee after Reuters published a series of articles in 2016 about the office’s approach to criminal investigations and controversies surrounding its spending, personnel matters and use of resources.

In testimony in March, Gottlieb talked about efforts at the FDA to combat the crisis, including stopping the importation of dangerous non-FDA approved opioids by last year tripling the number of FDA investigators at U.S. mail facilities and doubling the number of agents stationed at U.S. ports of entry to prevent illegal drugs from hitting the streets.

From the end of September 2017 through January 2018, of about 5,800 suspicious packages that FDA inspected through its port of entry initiative, 376 were controlled substances such as opioids, and were referred back to Customs and Border Patrol for seizure.

However, one source familiar with the effort told Reuters on Sunday the initiative is not generating many new investigative referrals that could help lead to prosecutions, and added that it duplicates efforts by investigators in the U.S. Department of Homeland Security.

The committee is asking the FDA to provide statistical data about the cases being generated through the port of entry initiative and its prosecution track record by June 22.

Click HERE to read the full article online.

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