Drug Shortages: President Obama’s executive order
With the huge numbers of baby boomers rapidly aging and becoming more dependent on medications, drug shortages are reaching national crisis stage. Medicines in short supply include cancer treatments, pain medications, and anesthesia drugs, along with other lifesaving and critical drugs. The need has increased dramatically in the last five years, but production has not increased, and it could be years before supply catches up with demand, leaving patients in the lurch. In addition, many chemotherapy drug patents have expired over the last few years, and the generic industry has been slow to ramp up.
Last month, President Obama signed an executive order that requires the FDA to take action to help alleviate shortages by more comprehensive reporting of potential shortfalls, expediting regulatory reviews, and reviewing the behavior of market participants to prevent stockpiling or jacking up prices of scarce meds.
Early warning of a predicted shortage can help doctors, pharmacists and other health professionals prepare by diverting to a different medication where appropriate or finding alternative treatments. In many cases, advance knowledge has been effective in preventing shortages over the last few years. This has sparked a pending bipartisan bill that would require manufacturers to disclose potential shortages. Drug manufacturers are already required by law to report discontinuations, but the law is inadequate and has led to under-reporting, according to FDA Commissioner Margaret Hamburg, MD. President Obama’s office also issued a letter to drug manufacturers, reminding them of their responsibility, and urging them to voluntarily offer information in advance of a shortage.
In response to the White House initiative, the FDA plans to hire six more personnel for its Drug Shortage Program, more than doubling the current staff for that department.
Findings of inappropriate market behavior, for example price gouging or stockpiling, will be directed to the Department of Justice for investigation and prosecution.
One potential answer to drug shortages is education. It is clear that there will be shortages. One near future issue is an IV Pain medication, fentanyl, which is widely used in hospitals. It could be unavailable as early as the end of the year.
Drug shortages could hit independent pharmacies pretty hard. As we all know, dealing with customer frustrations can damage the pharmacy’s reputation and alienate long time customers. Add in drug shortages in small stores due to the clout big chains have to buy up all the available stores of common medications, and it’s a recipe for disaster. What would you add to the president’s initiatives to help alleviate shortages and make sure customers get the meds they need? Given the unprecedented number of drug patents poised to expire in the near future, how much trouble could the medical industry be facing?