Lawmakers on both sides of the aisle are seeking to strengthen the U.S. medical supply chain as shortage concerns mount in the midst of the deadly coronavirus outbreak.
The number of people with COVID-19 in the United States climbed March 3, with Washington state reporting three more deaths. According to the Centers for Disease Control and Prevention (CDC) figures as of March 4, 80 people have been infected in 13 U.S. states, including presumed cases reported by public health laboratories.
In a bipartisan House initiative, Reps. Mike Gallagher (R-Wis.) and Mark Pocan (D-Wis.) introduced on March 2 the Medical Supply Chain Security Act.
Our overreliance on products made in China doesnt just threaten our medical supply chains. It threatens public health, Gallagher said in a statement.
Pocan said, With the continued spread of the coronavirus resulting in numerous deaths in the United States, it is imperative that we provide the FDA with tools they need to better prepare for responses and shortages in medical supplies.
Sen. Josh Hawley (R-Mo.) introduced companion legislation in the Senate last week.
The coronavirus outbreak in China has shed light on what Hawleys office called severe, longstanding, and unresolved vulnerabilities in the U.S. medical product supply chain, which threaten shortages of essential medical goods as many Chinese factories remain closed in an attempt by the Chinese regime to prevent further spread of the virus.
The Food and Drug Administration (FDA) recently identified about 20 drugs that solely source their active pharmaceutical ingredients or finished drug products from China, the agency said, while Health and Human Services (HHS) Secretary Alex Azar told Congress on Feb. 25 that the United States has a stockpile of about 30 million respiratory masks, but might need as many as 300 million during the outbreak.
This is more than unfortunate, Hawley said in a statement. Its a danger to public health.
Last week, the FDA said its aware of 63 manufacturers, representing 72 facilities in China, that manufacture essential medical devices that may be more prone to shortages due to a supply chain disruption.
The Medical Supply Chain Security Act (pdf) would give the FDA the authority to analyze sourcing locations of medical products and, in case of shortages, help bring products to market faster.
Our health officials need to know the extent of our reliance on Chinese production so they can take all necessary action to protect Americans, Hawley said. This legislation will give us the information we need to better secure our supply chain and ensure that Americans have uninterrupted access to life-saving drugs and medical devices.
The new bill will require that manufacturers report to the FDA imminent or forecasted shortages of life-saving or life-sustaining medical devices. That would let the FDA expedite the review of essential medical devices that require pre-market approval in the event of an expected shortage reported by a manufacturer.
By allowing the FDA to identify our overreliance and swiftly take the necessary corrective actions, this bill would allow us to get upstream of potential shortages and better protect Americans access to critical medicines and lifesaving supplies, Gallagher said.
The measure also will give new authority to the FDA to request information on essential drugs or devices from manufacturers. The new notification requirements would cover all aspects of manufacturing capacity, including sourcing of component parts and active pharmaceutical ingredients, along with any other information that federal authorities need to assess the security of the U.S. medical product supply chain.
We need this legislation because currently no law exists requiring medical device manufacturers to notify the FDA when they become aware of a potential shortage or even requiring them to respond to the FDAs requests for information about the medical device supply chain, said Pocan.
Public health officials have urged common-sense steps to prevent contracting and spreading the novel coronavirus, such as frequent hand-washing and staying home when sick.MAGA
As of 2018, China claimed 13.4 percent of all import lines defined as distinct regulated products within a shipment through customsamong countries that export drugs and biologics to the United States. I would prefer that number would be 0%,
As far as who to blame..who knows? Countries have been trading pharma with China since the 1800's. If you want to blame someone, blame big pharma for being greedy.
Brand Name Drug Sold in U.S. Country of Manufacture Abilify Japan Advair Diskus UK Advair HFA* UK Afluria Australia Aggrenox Germany Alphagan P USA Amitiza USA Armour Thyroid USA Asmanex Twisthaler Singapore Atripla Canada Avodart Ireland Azor Germany Benicar Japan Benicar HCT Japan Bystolic USA Carafate Oral suspension Canada Celebrex Singapore Chantix Ireland Cialis USA (Puerto Rico) Combigan USA Combivent Respimat Germany Crestor Belgium Dexilant Japan Diovan USA Dulera UK Durezol USA Effient Japan Eliquis USA Enbrel USA Epiduo Canada Exelon Germany Exforge Switzerland Flovent HFA UK Focalin XR USA Humalog USA Humalog Kwikpen USA Humira USA Humulin R USA Invokana Italy or USA (Puerto Rico) Janumet UK Januvia UK Lantus Germany Lantus Solostar Germany Latuda Japan Levemir Denmark Levemir Flexpen Denmark Levemir Flextouch Denmark Linzess USA Lo Loestrin Fe Germany Lotemax (gel) France Lumigan Ireland Lyrica Singapore Minastrin 24 Fe USA (Puerto Rico) Myrbetriq Japan or Italy Namenda USA Namenda XR Ireland Nasonex Singapore Nexium Sweden Norvir Italy Novolog Denmark Novolog Flexpen Denmark Novolog Flxpen Mix 70/30 Denmark Nuvaring Netherlands Onglyza Ireland Ortho-Tri-Cyclen Lo 28 USA (Puerto Rico) Oxycontin USA Pataday USA Patanol USA Pradaxa Germany or Italy Premarin Canada Premarin Vaginal Cream Canada Pristiq Singapore Proventil HFA Italy Ranexa USA Relpax Ireland Seroquel XR Belgium Spiriva Handihaler Germany Strattera USA or UK Suboxone USA or UK Symbicort France Synthroid USA (Puerto Rico) Tamiflu USA Toprol-XL* Sweden Tradjenta Germany Travatan Z USA Truvada Canada Uloric Italy Ventolin HFA UK Vesicare Ireland Viagra Ireland Victoza 3-Pak Denmark Viibryd Taiwan Voltaren Gel Germany Vytorin Singapore Vyvanse USA Welchol Austria Xarelto Germany or USA (Puerto Rico) Xopenex HFA USA Zetia USA Zostavax USA