Obama’s Action to Reduce Drug Shortages: The Industry Reacts

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Earlier this month, <em>Scrubs &amp; Suits</em> reported that <a href="../../news/obama-to-fda-take-steps-to-prevent-future-drug-shortages-for-lifesaving-medicines">President Obama had issued an executive order</a> that directs the FDA to take steps to &ldquo;prevent and reduce current and future disruptions in the supply of lifesaving medicines.&rdquo;</p>
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Shortly after the White House announced Obama&rsquo;s plan, it released a video of Bonnie Frawley, a pharmacy manger for Brigham and Women&rsquo;s Hospital in Boston, MA. In the video (above), Frawley discusses how drug shortages affect patient care on a day-to-day basis.</p>
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A <a href="http://www.youtube.com/watch?feature=player_embedded&amp;v=EkJBFEAGQwA">second video released by the White House</a> features cancer patient and advocate for drug shortage reform Jay Cuetara, who speaks on the President&rsquo;s executive action. He discusses Obama&rsquo;s plan and explains why he believes it&rsquo;s a step in the right direction.</p>
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In addition to releasing the executive order, the Obama administration reported that it <a href="http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277675.htm">sent letters to pharmaceutical companies</a> to remind them of &ldquo;their responsibility to report the discontinuation of certain drugs to the FDA.&rdquo;</p>
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Also, the letter asks drug manufacturers to voluntarily take steps above and beyond the requirements of the current law and to inform the FDA about issues relate to drug shortages.</p>
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&ldquo;We are committed to continuing to identify the problems that lead to drug shortages and to establishing processes to resolve and avoid critical shortages in the future,&rdquo; wrote Margaret Hamburg, MD, the FDA&rsquo;s commissioner of food and drugs.&nbsp; We seek your commitment to do the same.&nbsp; Clear, ongoing, and timely communications between the FDA and industry are essential to preventing many drug shortages, mitigating those that cannot be avoided, and facilitating the resolution of ongoing shortages.&nbsp;</p>
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Kasey Thompson, VP of policy, planning and communications for the American Society of Health-System Pharmacists (ASHP) said that the FDA needs to find out how so-called gray market entities can obtain medications, especially when they&rsquo;re not available elsewhere in the supply chain.</p>
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Thompson told ASHP reporter Kate Traynor that the drug manufacturers are now on notice and understand that the Obama administration is serious about the industry&rsquo;s obligations to notify the FDA of expected or potential drug shortages.</p>
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&quot;I think we&#39;re not going to see an overnight resolution in drug shortages because of this action, but I really want to speak to how positive it is that the President took this step,&quot; Thompson <a href="http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=3635">said</a>, in the interview with Traynor.</p>
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Thompson went on to say that the Obama administration has basically called for enhanced capacity for the FDA to inspect drug manufacturing facilities, review product applications and to take other actions related to drug shortages.</p>
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That&rsquo;s probably why the White House recently announced that it is creating a &ldquo;surge team&rdquo; made up of six to eight federal experts who will assist the FDA&rsquo;s four-person Drug Shortage Program, tasked with taking steps to prevent or alleviate drug shortages.</p>
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Peter Carmel, MD, president of the AMA, said that addressing the issue of national drug shortages is &ldquo;multifaceted and complex, but the changes announced by the administration are a step in the right direction.&rdquo;</p>
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&ldquo;The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety,&rdquo; said President Obama in a <a href="http://www.whitehouse.gov/the-press-office/2011/10/31/we-can-t-wait-obama-administration-takes-action-reduce-prescription-drug">White House press release</a>. &ldquo;This is a problem we can&rsquo;t wait to fix. That&rsquo;s why today, I am directing my administration to take steps to protect consumers from drug shortages, and I&rsquo;m committed to working with Congress and industry to keep tackling this problem going forward.&rdquo;</p>
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<strong>What do you think about the drug shortage situation? Will drug shortages continue to increase, or are these steps enough to help bring them to a stop? Share your thoughts in the comments. </strong></p>
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