1. Pink Sheet
  2. >>Compliance
  3. >>Distribution/Supply Chain

Remdesivir Distribution Begins With More Questions Than Answers

 
• By Sarah Karlin-Smith

Ethicists decry the government's opaque approach, highlighting the potential risks of a fast US FDA emergency authorization if supply isn't able to support demand following regulatory clearance. AmerisourceBergen is distributing the drug for the government, but within the Administration, no agency appears to want to take public responsibility for the decisions about where the doses of the COVID-19 treatment are sent.

Gilead sign at headquarters in Silicon Valley. Gilead Sciences, Inc. is an American biotechnology company that researches, develops and commercializes drugs - Foster City, California, USA - 2020
The benefits of Gilead's speedy emergency use authorization for remdesivir may limited due to limited supply and distribution challenges • Source: Shutterstock

Nearly a week after the US Food and Drug Administration granted an emergency use authorization to Gilead Sciences Inc.’s remdesivir for the treatment of COVID-19 it remains unclear how much drug the US government has access to and how it is deciding where to send the medicine throughout the country.

Based on informally collected data accumulated to try and fill in the gaps from official sources, it appears that the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Distribution/Supply Chain

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

More from Compliance

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
• By Derrick Gingery

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.