Congressional action on compounded drugs is looking more likely in 2013 now that two legislators from Tennessee – one of the states hardest hit from the meningitis outbreak – are expected to take over leadership of two major Senate and House committees. Is FDA legislation inevitable?
They say that all politics is local. That may prove especially true in the case of compounded drugs.
Since the meningitis outbreak associated with a compounded injectable steroid first surfaced a month ago, Tennessee has been one of the states hardest hit. More than 80 cases of fungal meningitis have been reported in Tennessee, including 13 deaths, according to the Centers for Disease Control & Prevention. Only Michigan has reported more incidents of infection, at 119 cases, with seven deaths.
Now two Republican members from Tennessee, Sen. Lamar Alexander and Rep. Marsha Blackburn, are poised to take leadership positions on two Congressional committees with the greatest oversight of the Food & Drug Administration. And that means that the future of pharmacy-compounded drugs – and FDA’s regulation of it – is likely to be front-and-center in 2013.
Sen. Alexander is widely expected to take over as Ranking Member of the Senate Committee on Health, Education, Labor & Pensions (HELP) from Sen. Mike Enzi (R-Wyo.) at the beginning of the next session. Sen. Enzi has served six years as Ranking Member of the Committee, and thus is term-limited out under the rules of the Senate Republican Conference.
On the House side, the primary defeat of Rep. Cliff Stearns (R-Fla.) will leave the chairman post of the Energy & Commerce Oversight & Investigations Subcommittee vacant next session. Rep. Blackburn recently signaled her interest in heading that subcommittee. That change is a bit less certain; another viable candidate would be Rep. Lee Terry (R-Neb.).
Both committees already have hearings scheduled: the Oversight & Investigations hearing is November 14, and the Senate HELP hearing is November 15. FDA Commissioner Margaret Hamburg, MD, is scheduled to speak at both hearings. The witness list for the Senate hearing also includes Barry Cadden, the owner of the New England Compounding Center, the facility that has been linked to the outbreak.
So far, FDA has been reluctant to ask for additional authority to regulate the pharmacy compounding industry, especially since any new regulatory power is unlikely to come with new funding to help pay for it. But recent comments by agency officials appear to acknowledge that the issue needs to be revisited to ensure the safety of patients using compounded drugs.
“The world has changed a lot since the days of mortar and pestle, and this is the time for pharmacists, for lawmakers, for regulators and for doctors to sit down to grapple with this new model of pharmacy compounding and come up with a regulatory scheme that appropriately controls the risk,” FDA Deputy Commissioner for Global Regulatory Operations and Policy Deborah Autor said October 11.
With the potential for new committee leadership from Tennessee – in addition to existing leadership from Michigan in House Energy & Commerce Committee Chairman Fred Upton – Congress seems ready to address the issue. We’ll have much more to say on pharmacy compounding in an upcoming issue of The RPM Report. Stay tuned.
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