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From FDA Week – 4/19/2013 – Obesity treatment advocates applauded an amendment to the Risk Evaluation and Mitigation Strategy for one of two obesity drugs approved by FDA last year, allowing it to be sold in some retail pharmacies. However, a consumer safety advocate said the decision is another example of FDA caving to industry pressure to provide access to obesity drugs that could pose serious health risks as it was motivated by the drug’s manufacturer, Vivus, Inc., which seeks to expand its market reach.

Vivus said Tuesday (April 16) that FDA approved an amendment to the REMS for its weight loss drug Qsymia that would allow it to be sold in certified retail stores. FDA’s approval of the drug last year hinged on the application of a REMS that consisted of a medication guide, voluntary prescriber training and the company’s proposal that the drug only be available through mail-order pharmacies.

The company has said the modification will allow it to increase the availability of Qsymia by simplifying prescribing and dispensing of the drug, which were challenging in the mail-order system.

However, Scott Kahan, director of Strategies to Overcome and Prevent Obesity Alliance, said the REMS for Qsymia was overly stringent to begin with, pointing out that neither phentermine nor topiramate — the two drugs combined in Qsymia — have REMS.

He also said he believed FDA initially required the restrictive REMS because of concerns about potential misuse of the drug by those outside of the target population of patients who are overweight with weight-related co-morbidities. He said the modification could signal that other obesity drugs will have a “fairer” regulatory assessment in the future. However, Qsymia’s REMS modification might not be the game changer obesity drug developers are looking for, Kahan said.

“I don’t think you can read too much into this specific announcement,” he said. “It’s an important announcement, but it’s not a game changer.”

One obesity treatment researcher said prescribers have struggled to fill prescriptions for Qsymia because the mail-in distribution system does not accept electronic records. Louis Aronne, director of the comprehensive weight control program at New York-Presbyterian/Weill Medical Center, said because electronic records are now considered more efficient, physicians are typically required to fill a certain percentage of their prescriptions electronically. However, that could not be done with Qsymia because it was a controlled substance.

Aronne said the average physician was probably deterred by the distribution system and chose not to prescribe the medication to patients. Other sources noted Qsymia has not had the market success the company expected, and that could largely be due to its restricted distribution.

“What I think the FDA does not want to do is restrict access,” Aronne said. “I think the FDA has asked Vivus to set this program up and I think they’ve shown they’re able to control the distribution of it.”

Aronne added that if other obesity drug developers can similarly show that they are able to control distribution, they could be more likely to receive FDA approval.

Yet, a consumer safety advocate questioned why FDA would make the obesity drugs more widely available when there is still no additional data to show that their benefits outweigh risks.

Sidney Wolfe, director of Public Citizen’s Health Research Group, criticized FDA for removing one of the few safeguards against misuse of the obesity drug.

“FDA was reckless in the approval of this case and they’re being reckless with loosening the safeguards,” he said.

Restricted distribution of Qsymia was especially important since other elements in the REMS, like voluntary prescriber and educational materials for patients, were “weak,” Wolfe said. He added that the risks posed by the drug are not going to be any less because patients are being told there is an increased chance for adverse cardiovascular events.

Wolfe opposed the approval of both Qsymia and Arena Pharmaceutical’s Belviq last year. Belviq, which has not yet launched, does not have a REMS program.

An FDA spokeswoman said that the REMS modification is in keeping with the approval letter the agency sent to the company in July, which requested Vivus develop a plan that would allow Qsymia to be available at a broader range of pharmacies.

“When a proposed REMS modification is submitted, a REMS assessment must also be submitted,” the FDA spokeswoman said. “FDA approved Vivus’ REMS modification after review and agreement on the proposed revised REMS and REMS materials and after review of the submitted REMS assessment.” Vivus submitted the plan to FDA in October.

“Our goal over the next three months is to ensure availability to Qsymia in thousands of certified retail pharmacies nationwide,” Peter Tam, Vivus’ president, said in a statement. “The REMS modification is a key accomplishment in removing a major barrier that has hindered the initial acceptance of Qsymia into everyday medical practice. We believe that retail access, along with ongoing improvements in reimbursement, will help accelerate Qsymia awareness, trial and usage.” — Stephanie Beasley

FDA Week – 04/19/2013, Vol. 19, No. 16