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Relying On Perfection In An Imperfect World: ADHD Drug Shortage Could Spur Push For DEA Reform

 
• By Sarah Karlin-Smith

Ongoing stimulant shortages leads to calls for DEA to allow for more elasticity in the supply chains of drugs with potential for abuse, but in wake of ongoing opioid crisis agency appears willing to potentially shift but not up quotas. 

US Drug Enforcement Administration flag
The DEA quota system adds extra layers of complication to the ADHD medication shortage • Source: Shutterstock

The ongoing shortage of stimulant medications used to treat ADHD is placing a target on the US Drug Enforcement Administration and its complicated system for allocating quota of controlled substances deemed at high potential for abuse as the tightly regulated process seems to be making it too difficult for manufacturers to adjust to changes in the supply chain.

Key Takeaways

  • ADHD drug shortage situation lacks some of the “typical” shortage characteristics. Sources said the medicines are profitable to make and there are more than a dozen manufacturers.

The ADHD drug shortage doesn’t match the typical characteristics of US drugs in short supply, which are often complex older...

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• By Eliza Slawther

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UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

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• By Ewan Townsend

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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.

More from Compliance

Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By Sue Sutter

Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.

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

 
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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.