The opioid crisis also has drawn attention of Congressional leaders. The Senate Finance Committee launched an investigation in May 2012 of financial ties between opioid manufacturers and pain experts, looking for links between pharma industry money and the surge in inappropriate drug use. Sen. Joe Manchin (D-WV) sought to add stronger controls on certain opioids to last year's FDA Safety and Innovation Act (FDASIA), but backed off when FDA promised to address the issue this year. The development of new opioids with anti-abuse features also is spurring legislative proposals to block generic versions of older, easily tampered products.
PUSH FOR CONTROLSFDA's immediate task is to weigh the scientific and medical merits of a proposal from the Drug Enforcement Administration (DEA) to impose stricter controls on drugs such as Vicodin (combination of hydrocodone and acetaminophen). DEA initially petitioned FDA in 2004 to evaluate evidence for reclassifying hydrocodone combination products from schedule III to schedule II under the Controlled Substances Act (CSA). This "upscheduling" would impose more stringent recordkeeping and storage requirements on 81 marketed combination medicines, virtually all of which are generic drugs. Schedule II prescriptions cannot be refilled or phoned in by doctors, and nurse practitioners and physician's assistants can't write scripts. The fear is that going to the doctor every three months for a new prescription could over-burden individuals who are coping with chronic pain.
Opposition to DEA's proposal came from the Generic Pharmaceutical Association (GPhA), which predicted supply-chain problems as manufacturers and wholesalers face requirements for larger vaults and new systems for storing controlled ingredients and finished goods. Pharmacists complained about a host of costly new security procedures, while practitioners predicted access problems for patients suffering from cancer, trauma, and post-operative pain. Despite FDA skepticism about the policy change, the advisory committee voted 19–10 in favor of DEA upscheduling, and FDA is expected to follow the panel's advice.
These issues were re-examined a week later at a February FDA public hearing on proposals to add stronger labeling and warnings on opioid painkillers. Physicians for Responsible Opioid Prescribing had petitioned FDA to revise labels to limit opioid treatment to 90 days and to patients with "severe" and not "moderate" pain. Again, dozens of stakeholders testified on abuse and access issues. Family members of addicts complained that existing labels fail to adequately inform doctors or patients of the severe risks of the drugs; pain specialists opposed arbitrary limits, emphasizing the need for flexibility to treat patients based on individual needs. There was discussion about whether a drug track-and-trace system, using serialization to identify individual units, could curb illegal opioid distribution. Pharmacists supported this approach, along with use of electronic medical records and drug monitoring programs to identify dangerous drug use.