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Pallone Bill to Empower FDA to Combat Illicit Opioid Importation Passes House

June 12, 2018
Press Release

Washington, DC- Congressman Frank Pallone, Jr.’s (NJ-06) bill to provide increased funding to combat illicit opioid importation today passed the House of Representatives unanimously. H.R 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now (SCREEN) Act, will also expand the Food and Drug Administration’s (FDA) authority to prevent illegally manufactured opioids, such as fentanyl, from arriving overseas through the mail.

One of the many ways synthetic opioids reach the United States is through International Mail Facilities (IMFs), which receive millions of parcels containing illegal or unapproved drugs annually.

Pallone led the debate on the House floor today on the SCREEN Act. You can find video of his remarks here.

Last month, Pallone, Congressman Bill Pascrell (NJ-09) and United State Postal Service (USPS) and Food and Drug Administration (FDA) officials toured the New Jersey International Bulk Mail Center in Secaucus, NJ and discussed the importance of the SCREEN Act.

The SCREEN Act would:

•           Allow FDA to destroy more than $2,500 worth of drugs (the maximum under current law) if the Agency determines it would be in the interest of public health to do so.

•           Authorize FDA to issue an Emergency Recall Order and to cease distribution of drugs that may pose an imminent or substantial hazard to public health.

•           Grant FDA authority to refuse importation and destroy drugs on the basis that they have been identified to DEA as “articles of concern”, as well as to refuse, destroy or find to be misbranded, unlabeled or minimally labeled imported products that contain active ingredients.

•           Authorize $110 million to FDA for fiscal years 2019 through 2023 to support innovation in non-opioid and non-addictive pain treatment, programs to increase access to opioid use disorder treatment, and to reduce illicit importation of opioids, including increasing staff capacity at IMFs.

The text of his remarks on the House floor can be found below:

Mr./Madam Speaker, I rise to voice my strong support for H.R. 5228, legislation that I authored that will strengthen FDA’s ability to prevent illicit opioids from coming in through our international mail facilities by providing the agency with additional enforcement authority and financial resources.

In April, I had the opportunity to visit an international mail facility in my home state of New Jersey with the Food and Drug Administration, Customs and Border Patrol, and the United States Postal Service to see firsthand the problems these agencies are facing when it comes to illegal, unapproved drugs entering our country through international mail facilities.

FDA staff showed us boxes of pills that had limited labeling, labeling in foreign languages, or no labeling at all and were sent from unknown and unregistered facilities. FDA staff explained that it takes the agency days to catalog these boxes, identify what products contained inside are legitimate, and identify what products under current law the agency can destroy.

FDA then has no other option but to return that box to the sender. This leaves  open the possibility that the sender will just drop the box of illegal pills back in the mail to try and enter the country again through another international mail facility.

The agency also showed me a series of similarly wrapped and marked packages that contained little labeling and were misidentified as gifts. Upon inspection, these packages included  bags of drugs labeled in another language. Again, the agency faced the task of trying to prove the product was a drug before it was able  to take further action.

The SCREEN Act, which passed the Energy and Commerce Committee by voice vote, would give FDA authority to act in these situations to stop illicit drugs from entering the marketplace and allow the agency to better target their resources.

Specifically the SCREEN Act would:

  • Expand FDA’s authority to refuse or destroy illegal drugs;
  • Provide FDA with the ability to order manufacturers to cease distribution, or to recall drugs that pose an imminent or substantial hazard to the public health;
  • Allow FDA to refuse admission or to destroy bulk shipments of drugs from a manufacturer, distributor, or importer if they are found to be misbranded or adulterated; and
  • Authorize new resources to help provide additional capacity at international mail facilities and to upgrade infrastructure, equipment, and other needed technology for screening purposes.

Having worked closely with FDA on this legislation, I know that the authorities outlined in the SCREEN Act will go a long way towards empowering the agency to take on repeated illicit drug traffickers and ensure that dangerous, unapproved drugs are stopped at our ports and mail facilities.

            I urge my colleagues to vote in support of this bill.

            Thank you.