The Food and Drug Administration Amendments Act (FDAA) passed by congress in September of 2007 provides the FDA with new expanded authority to require Risk Evaluation and Mitigation Strategies (REMS) for drugs and biologicals.
Essentially the FDA can now require the manufacturer of any drug to develop and submit a REMS if the FDA determines that it is necessary to ensure that the benefits of the drug outweigh the risks of drug.
This applies not only to applications for new drugs, but also to drugs that have previously been approved by the FDA and are currently in use by patients. The decision to require REMS for an existing preapproved drug may be triggered at any time if the FDA becomes aware of new safety information that makes the determination necessary in the opinion of the agency.
The REMS are required to contain one or more of the following elements; a patient medication guide, communication plan to healthcare providers, and more complex components to assure safe use (such as a restrictive distribution plan, special training for prescribers and pharmacists, and patient, pharmacy, and prescriber registries). The law states that a REMS should not have "unduly burdensome" effects on patient access to medication, however there are no guidelines or examples offered as to what would constitute an undue burden.
Letters were sent to all of the opioid drug manufacturers on February 6th 2009 to inform them that the FDA has determined that they would be required to develop a comprehensive REMS plan. The purpose of the REMS, according to the FDA, is to ensure that the benefits of the opioids continue to outweigh the risks of misuse, abuse, and accidental overdose and to manage any known or potential serious risk associated with an opioid. The FDA's rationale for this approach is that despite numerous efforts taken by the agency, drug manufacturers, and others in the past, the rates of misuse, abuse, and accidental overdose of opioids has continued to rise over the past decade. The FDA believes that establishing REMS for opioids will reduce these risks, while still ensuring that patients with legitimate need will continue to have appropriate access. All of us in the hospice industry are aware of the need for the use of opioids for pain management in end of life care.
The FDA has specifically targeted all of the long-acting opioids, with heavy utilization in hospice care, including the following: morphine extended release tablets and capsules, oxycodone extended release tablets, oxymorphone extended release tablets, methadone, and the fentanyl transdermal patch.
A meeting between the FDA and the opioid drug manufacturers was held on March 3, 2009 as a follow-up to the FDA letter regarding REMS development. At this meeting Dr. Bob Rappaport, Division of Analgesics, Anesthetics, and Rheumatology Products Director (FDA) stated, "We expect all companies marketing these products to work with us to get this done expeditiously . If not, we cannot guarantee that these products will remain on the market." (The Pain Practitioner vol 1, no 2).
In subsequent meetings with the various stakeholders (including professional societies, consumer groups, industry representatives, providers, patients, and pharmacists), the FDA again indicated that long-acting opioids could be removed from the market if the benefits of the medications are not demonstrated to outweigh the risks.
Dr. John Jenkins, Director of the Office of New Drugs (FDA) stated: "We recognize this is going to be a relatively massive new program... the 21 million prescriptions is orders of magnitude greater than any other program now in place. It's likely that legitimate patients will see new procedures that will be in place for obtaining these drugs, but we hope to make those procedures not so intrusive that it impacts their ability to receive the products while still meeting the second goal of having an impact on safe use."
The recent actions and public comments from FDA regarding opioid medications should give all of us who serve hospice patients great concern. There is a real possibility of serious unintended consequences if the FDA doesn't get this right. If opioid REMS is not developed carefully, so as not to interfere with the appropriate medical care of legitimate patients, another layer of barriers will emerge resulting in even greater problems with under-treatment of pain than we already have today. Some of these unintended consequences may include:
A variety of groups and professional organizations are providing input to the FDA regarding REMS. One among many that has taken an aggressive approach is the American Academy of Pain Management. They have provided some concrete recommendations to help ensure an effective REMS plan that does not lead to unintended adverse consequences.
Continue to support the efforts of your local, state and national organizations to ensure that your hospice patients will continue to have appropriate access to these critical medications without formidable bureaucratic barriers.
Photo Credit: Erix!
|Onsolis is a transmucosal fentanyl product and is the only opioid product that has a REMS enforced by the FDA. Although abuse potential is greatly reduced by the delivery technology, doctors scarcely prescribe it due to the bureaucratic obstacles imposed by the REMS.
Onsolis delivery technology accomplishes what FDA wants (in principle), but the FDA indirectly restricts sales of this product due to seemingly arbitrary enforcement of the REMS policy.
If the small company that produces Onsolis has been forced by FDA to develop and comply with a REMS program, why won't FDA impose the same standards on all companies?
Why does the FDA refuse to halt sales, or impose penalties for opioid drug companies that will not develop an approvable REMS?
Why isn’t the unequally enforced REMS requirement suspended until a uniform policy has been developed?
The illegal opioid drug trade depends on the inactivity of the FDA. Companies whose product sales must be scrutinized are delaying, delaying, delaying.
Who in the FDA is benefitting from this delay? Is it time to follow the money?????
-- anonymous guy
Posted 5/31/2012 01:28:29 PM
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