Acronym of the week would be more accurate, but GDUFA will be used as a word so it might as well be defined as one. With the passage of the Food and Drug Administration Safety and Innovation Act on July 9, 2012, GDUFA (‘Generic Drug User Fee Amendments...
Pharma’s New Cliffhanger: Protecting Corporate Reputation in the Face of a Prescription Drug Abuse Epidemic
by Chartése Day, Managing Account Supervisor
pharmaceutical industry, most have
focused on the crisis of the patent cliffhanger: the loss of more than $30 billion in revenue due to patent expiration of prescription drugs once dubbed “blockbusters.”
However, a greater crisis awaits - one that impacts not only a company’s bottom-line, but also a pharmaceutical company’s greatest asset: its corporate reputation. Companies must brace themselves to handle the industry’s role in combating the prescription drug abuse epidemic.
While most major causes of preventable death are declining, drug overdoses are an exception. And, opioids seem to bear the brunt of the blame. A 2011 report from the Centers for Disease Control and Prevention revealed that most drug-related deaths were not the result of illicit drugs, such as heroin or cocaine, but instead were the result of prescription pain medicines, mainly opioids. Inappropriate use of opioids caused nearly 342,000 emergency department visits in 2009, according to government figures. The drugs were blamed for 16,000 deaths that year, up from 14,800 in 2008.
On July 9th, as part of a multi-agency effort to address the growing problem of prescription drug abuse and misuse, the U.S. Food and Drug Administration (FDA) announced a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications. The REMS, which affects more than 20 companies that manufacture opioids, introduces new safety measures to reduce risks and improve safe use of extended-release and long-acting opioids while continuing to provide access to these medications for patients in pain.
Key components of the REMS for long-acting and extended-release opioids include:
- Training for prescribers. Based on an FDA Blueprint, developed with input from stakeholders, educational programs for prescribers of long-acting and extended-release opioids will include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs. In addition, the education will include information on how to recognize evidence of, and the potential for, opioid misuse, abuse, and addiction, and general and specific drug information for long-acting and extended-release opioid analgesics.
- Updated Medication Guide and patient counseling document. These materials contain consumer-friendly information on the safe use, storage and disposal of long-acting and extended-release opioids. Included are instructions to consult one’s physician or other prescribing health care professional before changing doses; signs of potential overdose and emergency contact instructions; and specific advice on safe storage to prevent accidental exposure to family members and household visitors.
- Assessment/auditing. Once the FDA finalizes the blueprint for the prescriber trainings referenced above, companies will then be expected to achieve certain FDA-established goals related to the percentage of prescribers of long-acting and extended-release opiods that complete the training. Additionally assessments will be required to determine prescribers’ understanding of important risk information over time. The assessments also cover whether the REMS is adversely affecting patient access to necessary pain medications, which manufacturers must report to FDA as part of periodic required assessments.
At present, this plan presents a few challenges for opioid manufacturers.
First, how will the FDA set pharmaceutical company goals for physician participation in trainings, and how will companies be held accountable? As part of the White House Prescription Drug Abuse Action Plan, President Obama has endorsed a mandatory training program for doctors that prescribe opioids. However, to date there is no mandatory requirement that prescribers take the REMS training and no precondition to prescribing long-acting and extended-release opioids to patients. To make any physician training mandatory would require new a law to be passed. The FDA – in collaboration with the Drug Enforcement Agency (DEA), Office of National Drug Control Policy (ONDCP), and Substance Abuse and Mental Health Services Administration (SAMHSA) – is working with Congress to amend Federal law to require practitioners (such as physicians, dentists, and others authorized to prescribe) who request DEA registration to prescribe controlled substances to be trained on responsible opioid prescribing practices as a precondition of registration.
Second, with pharmaceutical companies being required to provide educational training to doctors, many in the public will say “isn’t this just another way for pharmaceutical companies to unduly influence doctors?” Fortunately, the FDA anticipated this and offered a solution. While pharmaceutical companies will be required to provide educational training programs on safe and appropriate use and prescribing of opioids, it is expected that companies will meet this obligation by providing educational grants to continuing education (CE) providers, who will develop and deliver the training.
With the prescription drug epidemic now rising to epic proportions, many pharmaceuticals fear that it’s only a matter of time before lawsuits are filed against them as the result of people who become addicted to opioids. Case in point: lawsuits were brought against a major multinational pharmaceutical company for people who committed suicides after taking its anti-depressant medication, even though the product included a black-box warning about suicidal thoughts.
And, I’d be neglect if I didn’t point out that while there are stringent requirements for companies, regulators and to some degree doctors in the fight against this epidemic patients seemingly walk away with a pamphlet and a prescription. Where’s the mandatory training for patients? We’ll save that for another article.
What it boils down to is that to protect their corporate reputation while fighting this battle, opioid manufacturers must protect their bottom-line by staying “above the line” and doing the right thing.
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