1. Pink Sheet
  2. >>Compliance
  3. >>Manufacturing

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.

  • Inflexibility of DEA’s quota system for controlled substances with abuse potential is coming under scrutiny as a key hurdle to solving the ADHD/stimulant drug shortage.

  • Reaction to US opioid crisis may have caused DEA’s risk-aversion pendulum to swing too far

The ADHD drug shortage doesn’t match the typical characteristics of US drugs in short supply, which are often complex older generics with just one or two

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 Manufacturing

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

More from Compliance

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.