FDA adopted this moderate approach for the opioid REMS even though FDA advisory committees rejected such a voluntary educational
campaign in July 2010 as too weak to curb abuse. But FDA faces fierce opposition from the medical community to any limited
distribution system for opioids, and a broader program would create oversight responsibilities far beyond FDA's capabilities.
FDA lacks authority to tell physicians what to prescribe, noted Janet Woodcock, director of the Center for Drug Evaluation
and Research (CDER). But FDA can require manufacturers to develop educational materials.
The Obama administration proposes to put teeth into this educational campaign by asking Congress to mandate physician training
on opioid use to obtain the DEA registration number needed to prescribe these and other controlled substances. But for now,
training is optional for the 600,000 health professionals with DEA licenses to prescribe these drugs. In 2000, Congress approved
legislation that requires eight hours of special training for physicians to prescribe and dispense buprenorphine for treating
opioid addiction, but this involves much more limited drug use and far fewer physicians. The prospect of Congressional action
in the near future is fairly dim, however, due to opposition to mandatory actions likely to limit access to pain meds from
the medical pain community as well as manufacturers.
Even though training is voluntary, requiring pharma companies to develop educational materials on opioid use for CME providers
raises a host of issues regarding industry involvement in provider education. Most states require CME for physicians to renew
medical licenses, which supports a vast physician education network involving both non-profit and commercial CME providers,
many certified by the American Council for Continuing Medical Education (ACCME). An Institute of Medicine (IOM) report in
2009 called for eliminating all industry support of CME as the only way to curb drug company influence on prescribers, and
many healthcare organizations are adopting such policies. Consequently, the $856 million that drug and medical device companies
provided for CME programs in 2009 was down almost 30 percent from $1.2 billion in 2007; although declining, the amount still
represents nearly half of the $2 billion spent on CME.
ACCME expects pharma companies will provide independent support for opioid-related CME activities, and most doctors won't
complain. Only 15 percent of physicians want to completely remove industry CME funding, according to a recent survey, although
88 percent acknowledge that commercial support biases educational presentations. Doctors evidently feel they can deal with
pharma bias, and they don't want to pay more for these programs.
FDA says it will review opioid course materials to eliminate any promotional slant, and ACCME cites a "firewall" policy that
permits pharma to fund educational efforts without any say on content or presentation. FDA also may look to outside opioid
experts to prepare some of the REMS training materials on prescribing to treat pain, which would moderate industry's role.
"It is essential that the information be independent and avoid any commercial overtones," emphasizes CDER deputy director
Douglas Throckmorton. Yet, the REMS plan raises objections. Rep. Mary Bono Mack (R-Calif.) complained to FDA commissioner
Margaret Hamburg that the agency's actions merely "punt to the drug companies when it comes to prescriber education."
Just how some 16 brand and generic firms will devise a single shared system for educating prescribers and patients, and for
monitoring the program's impact, is fairly murky. While components of the educational materials and MedGuides will apply to
all drugs in the class, each manufacturer also will have to provide drug-specific information. And a common approach is needed
to obtain independent audits of training quality and impact and to survey continuing abuse and deaths.
ACCME says it can support CME assessment by tracking how many physicians take training courses and how much they learn about
opioid prescribing. Yet, each company will be responsible for providing post-marketing safety information to FDA on its particular
products and will have to monitor CME programs.
It remains to be seen how the opioid REMS affects industry involvement in physician training. "FDA endorsement of industry
education should cause the critics of speaker bureaus and industry support of CME to embrace these techniques for improving
patient care," says John Kamp, head of the Coalition for Healthcare Communication. "But I'm not holding my breath."