Regulatory Focus™ > News Articles > Senators Call on FDA to Address Shortages, Drug Schedule

Senators Call on FDA to Address Shortages, Drug Schedule

Posted 06 January 2012 | By Alexander Gaffney, RAC 

Several US Senators made independent calls on the US Food and Drug Administration (FDA) this week to address both shortages and perceived excesses of certain drugs.

Kristen Gillibrand (D-NY) wrote to FDA and the Drug Enforcement Administration (DEA) on 5 January, accusing them of negligence for spending over a decade to determine if hydrocodone pills containing acetaminophen should be elevated from a Schedule III to a Schedule II drug. 

Under the Controlled Substances Act of 1970, pure hydrocodone is treated as a Schedule II drug, while the combination pills are subjected to the less rigorous Schedule III controls, which allow a prescription to be refilled up to five times instead of just once. This, critics say, has led to an excess of the drug that has resulted in, according to the Wall Street Journal, "hundreds of deaths and thousands of emergency room visits."

Gillibrand called on both agencies to accelerate their decision making and prioritize the completion of their studies.

Speaking in Buffalo, NY, on 5 January, Senator Chuck Schumer (D-NY) called for an end to drug shortages that have been the bane of patients and providers alike. Schumer is advocating on behalf of the Preserving Access to Life-Saving Medications (PALM) Act, which was introduced by Sens. Amy Klobuchar (D-MN) and Bob Casey (D-PA) in February of 2011.  The bill currently has 61 co-sponsors in the House of Representatives.

The bill would give the government the ability to go after price gouging and require manufacturers to alert FDA if they were made aware of any supply disruptions. The bill would also make price gouging during a shortage a federal offense.

Meanwhile, Senator Richard Blumenthal (D-CT) advanced provisions similar to the PALM Act during a news conference on 3 January held at Hartford Hospital. Blumenthal also raised the possibility of strategic national stockpile of pharmaceutical products, modeled after the strategic petroleum reserve.


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