OR WAIT null SECS
© 2023 MJH Life Sciences™ and Pharmaceutical Commerce. All rights reserved.
Government at all levels are trying to mobilize to address the crisis
On Feb. 29, the Drug Enforcement Administration issued a news release announcing that it had held a meeting with “industry leaders representing the prescription drug supply chain” during which “way to minimize pharmaceutical diversion while maintaining legitimate commerce and patient access.” And that’s about it for DEA pronouncements—no mention of new policies, and no mention of who attended the meeting.
The back story to this, though, is both indicative of the problems government and industry have had for years in addressing prescription drug abuse, along with a worsening of the abuse problem. At the beginning of the year, the Centers of Disease Control reported that opioid deaths had hit a new high in 2014—47,055, up 6.5% over the year before. This has occurred despite the implementation of prescription-drug monitoring programs (PDMPs) in most states, and significant tightening of opioid prescribing by the medical community and pharmacy managers. (The fastest-growing cause of opioid death is due to heroin; however, opioid deaths from prescription drugs remains the largest category, says CDC.)
For years, industry organizations including the Healthcare Distribution Management Assn. and others have complained that DEA is using a cudgel-like approach to prescription drug diversion control, dropping in on retail pharmacies and drug wholesalers and shutting down facilities because those facilities’ “suspicious order monitoring” systems were judged inadequate. Distributors responded that they cannot single-handedly enforce DEA rules across their customer base, and that DEA could help by calling out suspicious dispensers themselves. This dialogue has resulted in one forward step—Senate Judiciary Committee approval (on Feb. 11) of S. 483, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. (A House version, H.R. 471, was passed last summer.) That bill, among other things, sets up a collaborative process between DEA and distributors.
Congressional attention is more focused, however, on a broader bill, S. 524, the Comprehensive Addiction and Recovery Act, which was unanimously approved on Feb. 29 in a procedural vote (actual up-or-down voting comes later). However, various news sources report that the bill might run aground as amendments for funding it are considered, and both Democrats and Republicans are looking at the election-year implications of the bill. S. 524 proposes additional support of PDMPs, and services for drug addicts. (A companion version, H.R. 953, was also introduced.)
The drug abuse epidemic also has renewed White House attention, with President Obama proposing $1.1 billion in funding for addressing addiction therapies, PDMPs and increased availability of naloxone, a drug that counters the effects of an opioid ovedose, as part of his FY2107 budget.
Bills like S. 483 have been in Congress for at least two years; now, in an election year, it’s hard to say first whether the bills or funding will be enacted, and second, what effect they might have on addressing the dire scope of the problem.