President Obama couldn't wait to trample over the legislative process again. This week, he issued his 98th executive order on an irresistibly exploitatable policy issue: prescription drug shortages. Soon, "One a Day" won't just be a multivitamin. It'll be the rate of White House administrative fiats.
Federal officials darkly suggest that selfish industry "stockpiling" is endangering Americans' lives. "If we find out that prices are being driven up because shortages are being made worse by manipulations of companies or distributors," the White House further threatened, "agencies will be empowered to stop those practices. And the FDA and the Department of Justice will be investigating any kinds of abuses that would lead to drug shortages."
As usual, the underlying reasons for these marketplace conditions are gobsmackingly complicated. As usual, a significant portion of the fault lies with the government -- not evil corporate "abuses." And as usual, Obama's unilaterally imposed "solutions" promise to do more harm than good.
There's no question that drug shortages exist and that they have been on the rise. According to the U.S. Food and Drug Administration, 246 drugs are now scarce. It's a record. Why? I've rounded up just a few of the reasons:
-- DEA rules. In some cases, manufacturers have been ensnared by federal Drug Enforcement Administration regulations. Take Adderall, the attention-deficit hyperactivity disorder medication. As ABC News reported earlier this year, Shire Pharmaceuticals makes Adderall "and is under contract to provide the generic form of the drug to Teva Pharmaceuticals and Impax Laboratories, which mass produce the generic." According to Shire, their supplies have been hampered by DEA restrictions on the amphetamine-based medications, which are tightly monitored controlled substances.
-- FDA rules. According to the American Society of Health-System Pharmacists and other professional organizations, "several drug shortages (e.g., concentrated morphine sulfate solution, levothyroxine injection) have been precipitated by actual or anticipated action by the FDA as part of the Unapproved Drugs Initiative, which is designed to increase enforcement against drugs that lack FDA approval to be marketed in the United States." These industry experts point to additional new drug manufacturing approval processes that are "lengthy and unpredictable, which limits their ability to develop reliable production schedules."
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