Misleading drug info: Feds crack down but will it stop?
Sep 21st 2009 5:30PM
Updated Dec 3rd 2009 4:46PM
The FDA, which issued a letter of warning to Allergan on September 10, isn't dancing around the issue. It requested that Allergan immediately stop circulating promotional materials that the agency says are in violation of the Federal Food, Drug, and Cosmetic Act, which is a set of regulations that oversee the safety of products like Latisse. The move comes on top of an earlier one that warned the company about promotional materials for its Aczone cream for Acne Vulgaris.
Heather Katt, an Allergan spokeswoman, wrote in an email that the company had received the FDA's notice of violation letter. "The timeline display exhibit noted in the FDA letter is no longer being used, and we are working closely with the FDA to address all their concerns," she said.
Of course, Allergan is far from the only drug company the FDA has warned about its promotional materials. Recently, the FDA sent a warning letter to Bioniche Pharma saying the company didn't mention risks, overstated efficacy and broadened the approved application associated with Sotradecol, which treats varicose veins.
Johnson & Johnson (JNJ) was recently told its ad for Ertaczo Cream for athlete's foot, "broadens the approved indication, contains unsubstantiated efficacy claims about the product, and omits important risk information."
Similarly, Galderma Laboratories received a warning letter about allegedly misleading information for its Tri-Luma medication for a skin condition. And these are just a select few examples from September and August.
All too often, drug companies neglect to mention risks and overstate efficacy. In 2006, U.S. Public Interest Research Group found in a study of five years of FDA warning letters that prescription drug marketers made deceptive claims to doctors and consumers for about 150 different drugs between 2001 and 2005. The consumer advocacy group also found that FDA enforcement policies are ineffective. Among the key findings, "print ads, TV ads and website ads make up almost 80 percent of deceptive marketing aimed at consumers," the group said.
Since then, there hasn't been much success in cracking down on the practice. The subject of deceptive drug claims gained more attention when then-presidential candidate John Edwards in 2007 introduced proposals to stop misleading drug advertising.
Democrats attempted unsuccessfully to pass a law that would ban consumer-directed advertisements in the three years after a drug's approval. When the presidential campaign was in full swing in 2008, Democrats stepped up their scrutiny of the drug industry. But deceptive drug claims continue to thrive. After all, the FDA can only review so much advertising material.
In April, the FDA tried to tackle misleading information online, specifically on search engines. It sent letters to 14 drug companies, including Eli Lilly (LLY), Genentech, GlaxoSmithKline (GSK), Johnson & Johnson, Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche and Sanofi-Aventis (SNY) in addition to nearly 50 drug brands. The letters requested an immediate end to ads that tout the benefits of the drugs without also describing potential risks.
While the companies seem to have complied, there are likely more potential violations out there, as only about 50 products have been targeted by the FDA. And with pharmaceutical companies spending billions a year in marketing, it's hard to imagine that misleading promotion will end completely any time soon, especially since direct-to-consumer advertising works, as can be seen here.
As for Allergan, it likely has an interest in clearing up any potential issues with federal regulators sooner rather than later. It has forecast peak sales for Latisse topping $500 million a year. The compound was discovered accidentally when Allergan developed Lumigan, its anti-glaucoma drug. Scientists noticed the drug has welcome effects on the eye lashes.
Now, Allergan is thinking of using this drug to perhaps create a hair growing remedy for balding individuals. If it works, it could potentially be a blockbuster. Allergan, which is also the name behind wrinkle-fighting injection Botox, may rejuvenate that product as a drug that prevents migraine headaches. That could potentially boost the drug's sales by $1 billion yearly.