Sometime early this year, after two years of controversy, the FDA might finally release its revised proposal for more stringent regulations on opioid pain relievers. The following are the key questions—and answers—surrounding new regulations, as well as a look at other recent FDA actions, including increased scrutiny of diabetes and obesity drugs due to heart concerns.
Question: What’s the latest on the FDA release of new regulations for prescription opioids?
Answer: First, the back story: The controversy concerns the creation of a Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics amid a troubling boom in prescription drug abuse, addiction, and overdose, and an accompanying spike in deaths from opioid overdoses. Under a 2007 law, the FDA can require drug and medical device manufacturers to adopt a REMS to ensure that the benefits outweigh the risks of continued use and that patients are adequately informed. In this case, the strategy could impact how nearly 4 million patients receive long-acting and extended-release opioids annually, according to FDA statistics.
In February 2009, the FDA sent a letter to manufacturers of opioid pain relievers, proposing a classwide REMS that would require certification by a physician or pharmacist and restrict distribution of the drugs, among other provisions. In response, many healthcare providers and medical organizations warned of an increased regulatory burden that would negatively impact patients. Among the concerns: fewer primary-care physicians (PCPs) willing to manage patients with chronic pain, reduced access to medically necessary drugs in underserved communities, undermedicated cancer patients, and increased use of other drugs with less stringent oversight.
In response, the FDA dropped its proposal for a prescriber accreditation program and another for a patient registry. But an FDA advisory panel soundly rejected a revised REMS proposal in July, by a vote of 25-10. The panel criticized the new plans as being too lax, lacking a formal requirement f
Q: What will the new REMS likely include?
A: Based on the criticisms of FDA panelists in July, the revised REMS could mandate a training requirement for all prescribers. The program would likely be created by the FDA and not by the drug industry, as had first been proposed (many doctors have agreed that a centralized, standardized program would be far preferable to dealing with programs set up independently by drug manufacturers). The strategy also might govern immediate-release opioids, in addition to extended-release and long-acting formulations. The FDA could propose linking doctor education to an existing Drug Enforcement Administration registration, but that would require congressional approval.
Q: What was the outcome of safety deliberations over the diabetes drug rosiglitazone (Avandia)?
A: After several years of concern over a heightened risk of heart attacks and other heart problems among patients taking rosiglitazone for type 2 diabetes mellitus, the FDA sharply restricted its availability in September and required the manufacturer, GlaxoSmithKline, to submit a REMS. When implemented, the REMS will limit new prescriptions to patients who cannot achieve glycemic control with other medications and decide not to take the alternative (pioglitazone) for medical reasons.1 Other diabetes drugs have faced similar scrutiny: In October, the FDA rejected an extended-release form of the diabetes drug exenatide (Bydureon) due to safety concerns, citing the need for more studies from manufacturer Eli Lilly about its effect on heart rate.
Q: What’s the upshot of recent FDA actions on weight-loss drugs and supplements?
A: The FDA also cracked down on weight-loss formulations in 2010, declining to approve several new drugs, overseeing the withdrawal of Abbott Laboratory’s Meridia in October, and announcing a December recall of capsules marketed online as Fruta Planta. Safety concerns over the latter two were linked to sibutramine, a drug that is “known to increase blood pressure and/or pulse rate in some patients and may present a serious risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke,” according to the FDA. Additionally, the drug can interact “in life-threatening ways” with other medications, reinforcing the idea that hospitalists and other doctors should delve into patients’ recent history of weight-loss drug or supplement use.
Q: What should we expect from the FDA in the next year?
A: Analysts will be keeping an eye on the number of new drugs approved in 2011 to discern any new trends. As reported by The Wall Street Journal and other publications, the FDA gave 21 drugs the go-ahead in 2010, down from 26 cleared in 2009 and 25 approved in 2008. The dip has concerned some drug industry representatives, who warn that an overly cautious approach could lead to more delays in new drugs reaching patients. Of course, the lower number also could reflect a continued dry spell in the pipelines of many pharmaceutical companies. On the flipside, consumer watchdogs have expressed optimism that the FDA might be devoting more attention to safety. In November, for example, the FDA oversaw the pulling of popular painkiller propoxyphene (marketed as Darvon and Darvocet) after evidence accumulated that the medication can cause potentially fatal heart damage and rhythm abnormalities.
Bryn Nelson is a freelance medical writer based in Seattle.
1. Woodcock J, Sharfstein JM, Hamburg M. Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med. 2010;363(16):1489-1491.