The AMA's decision to classify obesity as a disease is a direct attempt to persuade biopharma companies to develop new therapies by making it harder for payers to decline coverage while applying pressure on the FDA to approve more drugs faster. And that could provide a serious incentive for the obesity therapies already in development while making the preclinical work in the field more attractive to Big Pharma companies--which have largely avoided the field after witnessing repeated marketing debacles for unsafe meds.
In arguing over the classification, the AMA's Council on Science and Public Health--which voted against the classification only to have the delegates overturn that decision--specifically cited development and regulatory concerns in its report on the debate. Under the positives, they wrote:
"More widespread recognition of obesity as a disease could result in greater investments by government and the private sector to develop and reimburse obesity treatments. Some argue that the Food and Drug Administration would face increased pressure to approve medications for obesity, and would therefore reframe their approval process to focus on the ability of pharmaceuticals to decrease adipose tissue rather than to improve other markers of metabolic health, such as blood pressure and lipid levels. There is current interest in developing a 'limited use' approval pathway that could facilitate the clinical review and FDA approval of prescription drugs. Antibiotics and drugs to treat obesity have been identified as appealing candidates for such a pathway. More effective medications on the market would likely spur physicians to prescribe, and patients to expect, pharmaceutical interventions for obesity. In turn, third party payers would be harder pressed to deny coverage."
Biotech companies have developed only two approved drugs for obesity since 1999, both very recent. One of those, Arena's ($ARNA) Belviq, only made it to the market a few weeks ago, after the DEA finally established its controlled-substance classification. Although approved before Vivus' ($VVUS) Qsymia, Vivus' drug made it to the market first. And Orexigen ($OREX) is trying to play catch-up with a follow-up Phase III study demanded by the FDA for its drug.
These drugs only trigger a modest loss of weight. But the AMA's assistance here could prove crucial in helping build sales, which have been notoriously slow in coming. Perhaps just as importantly, the AMA's new position on obesity could prove a boon for earlier-stage developers like Zafgen, which has been working on a treatment designed to produce dramatic weight loss.
Obesity meds have gone through a roller-coaster ride in recent years, buffeted by regulatory decisions and finding it hard to generate sales. None of that will change overnight. If the AMA does help spur a turnaround, it will take some time to complete. But the conditions for clinical drug development just improved. -- John Carroll, Editor-in-Chief. Follow me on Twitter and LinkedIn.