Congresswoman Diana DeGette

Representing the First District of Colorado
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Lawmakers to examine safety of drugs made overseas

Dec 9, 2019
Press Release
Hearing comes as concerns mount over FDA’s ability to effectively monitor foreign drug makers

WASHINGTON, D.C. – Forty percent of all prescription drugs approved for sale in the U.S. are manufactured overseas – but are they safe?

While drug makers in countries such as China and India are producing more and more of the prescription medications that Americans take every day, there’s increasing concern over the federal government’s ability to effectively monitor those overseas manufacturers to ensure the pharmaceutical products they are producing are both safe and effective for Americans to use.

On Tuesday, the House Energy and Commerce Committee’s Oversight and Investigations panel – which oversees the Food and Drug Administration – will hold a hearing to examine the agency’s ability to oversee the quality and safety of prescription drugs made overseas.

“With more and more drugs being made overseas, it is imperative that we do everything we can to ensure those drugs are both safe and effective for Americans to use,” said the panel’s chair, U.S. Rep. Diana DeGette (D-CO). “For years, our panel has been working to ensure FDA has the resources and authority it needs to properly monitor foreign drug makers. Yet, based on recent reports, it’s clear that there is still much more that needs to be done.” 

To receive approval to market a drug product in the United States, pharmaceutical manufacturers – both in the U.S. and overseas – are required to comply with certain FDA regulations designed to ensure those products are safe for Americans to use and as effective as advertised.

It is the responsibility of FDA’s foreign drug inspection program to ensure that drugs made in foreign facilities comply with the same FDA standards that apply to drugs made in the U.S.

For more than two decades, the nonpartisan Government Accountability Office has been raising concerns over the FDA’s ability to properly monitor overseas drug makers. In 1998, GAO issued a report to Congress citing FDA’s infrequent inspections of foreign facilities.

In 2007, the Energy and Commerce’s committee oversight panel held a hearing to explore the challenges that the FDA’s foreign inspection team was facing – including: the frequency of its inspections, its overall presence abroad, the availability of agency translators and the quality of its data on foreign facilities, among other things.

In 2012, Congress approved legislation to give the FDA new authority to inspect overseas facilities and hold foreign drug makers accountable. The legislation, among other things, prohibited foreign manufacturers from delaying or denying FDA inspectors access to their facilities and gave the agency authority to destroy products produced by manufacturers who refused to be inspected.

Despite those new authorities Congress gave to the agency, GAO recently found FDA’s foreign drug inspection program is still struggling to hire staff. As a result, the number of foreign facilities the agency has inspected over the last two years has declined.

In May, a former FDA inspector sounded alarms over the safety of prescription medications manufactured in China and India.

The warning came just months after DeGette and others sent a letter to FDA requesting information about its foreign drug inspection program following the recall of a popular blood-pressure medication manufactured in China and India that was found to have been contaminated with trace amounts of carcinogens.

More recent media reports have alleged instances of fraud by foreign drug manufacturers who have, among other things, been reportedly caught falsifying data to meet FDA’s drug-quality standards. The reports have further raised doubts about the agency’s ability to effectively monitor the nation’s drug supply.

Tuesday’s hearing will begin at 10:00 a.m. EST in Room 2123 of the House Rayburn Office Building. Officials from both the FDA and GAO are set to testify.

The hearing will be streamed LIVE online at the following link: https://www.youtube.com/watch?v=miVge_e2kQc&feature=emb_title

 

Witnesses set to testify Tuesday:  

Mary Denigan-Macauley, Ph.D.

Director, Health Care

Government Accountability Office

 

Janet Woodcock, M.D. 

Director, Center for Drug Evaluation and Research 

U.S. Food and Drug Administration