We recently had an opportunity to speak with Michael C. Barnes, Executive Director of CLAAD, about some of the obstacles and future trends that Life Sciences ADF drug manufacturers are facing today. Read his answers and begin to prepare for the FDA led discussions at CBI's Abuse-Deterrent Formulations Summit in March.
1. In your opinion, what is the biggest obstacle for the pharmaceutical industry in the implementation of abuse-deterrent formulation development programs?
The pharmaceutical industry faces several noteworthy obstacles. First, insurers have been unwilling to provide adequate coverage of ADFs. They have imposed overly burdensome benefit utilization management practices, including step therapy, prior authorization, and adverse tiering. As a result, many patients cannot afford ADFs. Luckily, states are stepping in and enacting legislation to ensure parity of access to ADFs.
Second, there has been a lot of push back against ADFs from critics pointing out that ADFs cannot deter all forms of abuse. They often argue that ADFs do not prevent people from taking too many pills and overdosing. These critics overlook the value of incremental improvements that ADFs offer in reducing the likelihood of diversion, misuse, abuse, and accidental exposure.
Third, with the introduction of the CDC’s controversial opioid prescribing guidelines, there will be even greater confusion as to professional discretion to prescribe opioid analgesics, including those with abuse-deterrent features.
2. What should be an opioid manufacturer’s biggest focus in the successful development of ADFs to be approved by the FDA?
Opioid manufacturers should focus on obtaining product-specific clarity in advance of human abuse liability (HAL) studies to determine how best to collect and report data of reductions in drug-liking and abuse.
3. How do you think the final guidance will affect the legislative agenda for a) a generic draft guidance and b) a non-opioid stimulant draft guidance?
The FDA has committed to releasing a generic abuse-deterrent opioid analgesics guidance this year. A non-opioid-analgesic guidance covering other controlled prescription medications, such as opioids for treatment of opioid dependence and stimulants, is also necessary but likely not to be released in 2016.
Generic opioid analgesic ADFs will create new competition among manufacturers and hopefully drive down the price of such abuse-deterrent medications. Once generics come to market, it will be easier to justify a full transition so that non-ADFs can largely be replaced by ADFs. If federal legislation is properly drafted and enacted, competition will also spur improvements in abuse-deterrent technology as medications with greater abuse-deterrent features supplant those with more rudimentary technology and benefits.
4. What are you most looking forward to learning from the FDA’s presentation on The Future of Abuse-Deterrent Formulations at CBI’s upcoming event?
I look forward to learning how the FDA plans to implement its recently introduced opioid action plan to spur innovation and generic ADF opioid analgesic product development and to learning FDA’s timetable for guidance on abuse-deterrent labeling of other classes of controlled prescription medications, such as opioids for the treatment of opioid dependence and stimulants.
Michael C. Barnes will be presenting this March at CBI's Abuse-Deterrent Formulation Summit. Don't miss CLAADS address "Examine Congressional Bills and CMS Policy Effects on ADF Development Deadlines and Development Efforts." Take this opportunity to join the FDA, your peers and this esteemed cast of industry experts at this forward thinking Life Sciences ADF event.
Michael C. Barnes is the executive director of the Center for Lawful Access and Abuse Deterrence (CLAAD), a national non-profit working to reduce prescription drug abuse.
He is also the managing partner at DCBA Law & Policy in Washington, DC. Mr. Barnes has authored more than 10 scholarly articles published in journals such as the Notre Dame Journal of Law, Ethics and Public Policy, presents frequently at conferences nationwide, and provides analysis for radio and TV networks, including CNN, HLN, and FOX News.
He previously served as confidential counsel in the White House Office of National Drug Control Policy.
(photo courtesy of kev-shine via Flickr)