Managing Risks and Challenges
“We don’t really have a means to influence industry as to what they decide to put their money into. To some extent that’s driven by the market or by the interest of companies,” Linda L. Porter, Ph.D., program director of NIH’s National Institute of Neurological Disorders and Stroke (NINDS), told GEN.
NIH hopes to stoke industry and foundation funding of abuse-resistant opioid and non-opioid pain drugs through public-private partnerships whose creation will be explored by a new Interagency Pain Research Coordinating Committee, established by President Barack Obama’s healthcare overhaul. Its members, announced last month, include biomedical researchers, representatives from nonprofit public advocacy organizations, and representatives of seven federal agencies that deal with pain research and patient care.
IOM also recommends public-private efforts in its 364-page report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, released in June. The report suggested that efforts in pain management could be modeled on a successful 30-year-old public-private cancer research program, the National Cooperative Drug Discovery group within NCI. Its goals include supporting multidisciplinary team research, addressing the need for new therapies with greater selectivity, using high-throughput screening and other technologies to speed up discovery, and fostering translational research.
About 100 million American adults have chronic pain, according to IOM. Pain costs the U.S. up to $635 billion annually in medical treatment and lost productivity. Despite such a large potential market, IOM found, several barriers discourage development of new pain drugs: “They include the unfavorable economics of developing drugs that may help only a small number of people, problems in finding the required animal models, lower international prices, competition from generics, high failure rates of new drugs in clinical trials, and tough new regulatory standards.”
IOM’s report came out two months after FDA began requiring a new risk management program of all developers of extended-release and long-acting opioid drugs. The program applies to drugs used primarily to manage chronic moderate-to-severe pain.
“It is unclear whether there is a link to commercial development of new abuse-deterrent opioids or novel nonopioid analgesics and the FDA’s efforts to create the extended-release and long-acting opioid REMS,” FDA spokeswoman Lisa Kubaska told GEN. “FDA had been actively encouraging companies to develop abuse-deterrent opioid formulations for a number of years prior to gaining the authority to require a REMS.”
While REMS can be a valuable tool against abuse and to monitor drug safety, it must not slow down innovation in pain drug development. Many have credited the REMS process with deterring companies, slowing down generic drug approvals while innovators implement the programs, and increasing the burden on doctors, pharmacists, and patients. Despite increased approvals in FY ’11 and more expected in ’12, FDA still fights the perception that reviews have slowed to an all-time low. One step toward ramping up approval of pain drugs would be by giving them accelerated-review status, which was recently proposed for antibiotics and already applied to rare disease drugs.
If Washington wants to further help, it can marry pain drug developers with public partners through the new consortium and two existing NIH initiatives: the Public-Private Partnership program and the new National Center for Advancing Translational Sciences, whose research priorities include repurposing existing approved drugs and rescuing drugs not approved. But as Dr. Porter correctly notes, it will ultimately be private investors, individuals, and institutions whose interest will drive pain drug development forward in coming years.