Senate leaders are urging the Division of Protection to prioritize the acquisition of generic medication manufactured in america, warning that the nation’s overreliance on overseas factories poses an “existential danger” to the navy.
In a letter final week, Sens. Rick Scott, R-Fla., and Kirsten Gillibrand, D-N.Y., requested Protection Division Secretary Pete Hegseth to supply details about medication or key elements bought from overseas sources and the way lengthy the division’s stock would final if China restricted exports. Additionally they sought particulars about whether or not the Meals and Drug Administration had imposed any import bans on the division’s suppliers.
The letter cited ProPublica reporting final yr that discovered the FDA allowed dozens of overseas drugmakers, principally in India and China, to proceed sending generic treatment to the U.S. even after the factories have been banned due to severe security and quality-control failures. Since 2013, ProPublica discovered, the FDA allowed greater than 150 medication or their elements into america from banned factories, together with antibiotics, anti-seizure medication and chemotherapy therapies.
The company has stated that the exemptions helped stop drug shortages and that factories have been required to conduct additional high quality testing with third-party oversight.
“Exempting these medication or services permits for substandard and doubtlessly unsafe medication to enter the U.S. market,” the senators wrote of their letter. “These exemptions can pose a menace to drug security for American customers.”
Scott and Gillibrand additionally famous they’re anxious about instability in international commerce and politics, which they stated can create “profound ramifications for the supply of medicines” and pose public well being and nationwide safety dangers.
9 in 10 prescriptions in america are for generics, lots of them made abroad. Final yr, the senators, who lead the Senate Particular Committee on Growing old, launched an investigative report demanding adjustments within the FDA’s oversight of the generic drug trade. Amongst different issues, they requested the FDA to alert hospitals and different group purchasers when troubled overseas drugmakers are given a particular go to proceed sending their merchandise to america.
This month, Scott and Gillibrand launched laws often known as the Clear Labels Act to assist sufferers, docs and pharmacists know extra concerning the medication they use and prescribe. The proposal requires prescription labels to reveal the unique producer in addition to the suppliers of key elements. The generic drug lobbying group has stated that the labeling necessities could be expensive and that drug producers already disclose nation of origin data beneath U.S. Customs and Border Safety guidelines. The commerce group for brand-name drugmakers stated the trade would “welcome conversations” about strengthening the provision chain.
ProPublica needed to sue the FDA in federal courtroom final yr to study extra about the place generic medication have been made and whether or not the company’s inspectors had ever flagged these factories for security and high quality lapses. ProPublica in the end created a first-of-its-kind device that empowers customers to search out the knowledge themselves.
Now, Scott and Gillibrand are turning their consideration to the drugs utilized by tens of millions of U.S. servicemembers, veterans and their households. They requested a briefing by the Pentagon to discover whether or not officers are prioritizing the acquisition of American-made medication.
Drug security consultants stated the push might in the end assist shore up a weak provide chain.
“Earlier than you may be deployed, you need to be secure in your drugs,” stated David Gentle, president of the impartial testing lab Valisure, which is conducting drug-quality testing for the Protection Division. “In the event you purposely add extra variability to your medication, you possibly can stop the deployment of 1000’s of troops and not using a single shot.”
Final yr, ProPublica engaged Valisure to check a number of broadly used generic medication and located a number of samples had irregularities that consultants say might compromise their effectiveness.
Vic Suarez, a retired Military medical supply-chain commander, stated he hopes the trouble within the Senate will result in stronger drug acquisition insurance policies.
“It is a nationwide safety subject. It’s an financial safety subject. And it’s a affected person security subject,” he stated.
The Division of Protection didn’t reply to a request for remark.
