Legal & Legislative Updates
Balancing Act: Limited Rx Meds
(Fall 2014) Taking action on opiate abuse in the U.S. is a balancing act between two dynamic approaches; those that want to stop opiate addiction in its tracts, the White House, Drug Enforcement Administration (DEA) and Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) which wants to ensure the drugs’ availability to patients in great pain who deeply need it.
White House, DEA and CDC officials want to limit painkiller prescriptions; referencing Americans’ consumption of 99% of the world’s hydrocodone, a controlled substance that is also the most widely prescribed drug in the U.S.
The FDA, while in agreement that opiates are over-prescribed and that tighter restrictions should be placed on products containing hydrocodone, places a stronger emphasis on the fact that 100 million Americans suffer from chronic pain and, therefore, wants to ensure safe and effective drugs are available to relieve their pain.
Meanwhile the Ensuring Patient Access to Effective Drug Enforcement Act, a bill to reduce prescription drug abuse, passed in the House with bipartisan support. This bill would amend the Controlled Substances Act by changing the definition of “imminent danger to the public health or safety” to include drugs that pose present or foreseeable health risks. Under this bill, manufacturers of prescription drugs registered with the DEA will have the opportunity to submit a “corrective action plan” before a drug is pulled from pharmacies.
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