In the third quarter, Irvine drug maker Allergan Inc. saw a big jump in selling costs as it spent an extra $35 million or so on ads for its wrinkle removers, breast implants and other medical cosmetics.
Spending on cosmetic procedures is starting to rebound, prompting the company to put more into marketing to “boost the sales trajectory,” Chief Executive David Pyott said on a conference call late last month.
Allergan’s push into medical cosmetics has made it a big marketer to consumers of products that patients solicit doctors for not because they have to, but because they want to.
The company largely has shaped medical cosmetics advertising, building on earlier “lifestyle” drug marketing by Pfizer Inc. and others.
“Broadcast and print advertising has been effective for many of our brands,” Allergan said in an e-mail.
Breaking new ground has brought challenges for Allergan, including warnings from regulators and a recent red flag from a consumer group.
In September, the Food and Drug Administration sent Allergan a letter about its Web site and other promotional materials for Latisse, a drug derived from a glaucoma treatment that was found to grow eyelashes.
The FDA called the information “misleading” because it omitted and minimized the drug’s risks, such as eye color changes, redness and the possibility of unwanted hair growth if Latisse is exposed elsewhere.
In August, regulators sent Allergan a warning letter about an ad for its Aczone acne medication, saying it overstated the drug’s effectiveness and omitted details and risks.
In April, regulators made Allergan put a “black box” safety warning on wrinkle-remover Botox that said the drug could spread beyond the area of injection, causing symptoms similar to botulism, including swallowing and breathing difficulties and even death.
“Any correspondence we receive from FDA is taken seriously,” Allergan said.
Last month, Consumer Reports magazine took issue with a TV ad for Latisse, saying it couldn’t “believe the level of glam-infused over-the-topness the commercial imparted, making a powerful prescription drug that can cost more than $100 a month sound like just a really, really cool new makeup item.”
Allergan didn’t directly address the Consumer Reports item but said its advertising isn’t intended as a substitute for getting medical advice on its products.
Lifestyle Drug Marketing
Drug advertising to consumers isn’t new—Pfizer brought “lifestyle drug” marketing into prime time with Viagra in 1998.
Allergan has gone beyond that with marketing for product uses that have even less of a connection to an actual medical condition.
Regulators want to ensure that drug ads have a “fair balance in the information between efficacy and risks,” said Connie Pechmann, a marketing professor at the University of California, Irvine’s Paul Merage School of Business. “The FDA gives pretty clear guidelines about what you can and can’t do,” she said.
Regulators provide specific regulations on promoting drugs and devices, according to Allergan. They also periodically release guideline documents with additional directions for ads.
Even so, “there is a degree of subjectivity,” the company said.
“My experience is that they’ll complain about even minor words that they think are misleading, particularly in direct-to-consumer advertising,” said Joel Hay, a professor of pharmaceutical economics at the University of Southern California.
Allergan and others are required to submit ads and other marketing to the FDA. Regulators recommend submitting them before they appear, the company said.
Two of Allergan’s products—Juvéderm for lower face wrinkles and Lap-Band for obesity and weight control—are considered medical devices. The FDA monitors device ads but doesn’t require companies to submit those promotional pieces for review, Allergan said.
The company’s policy is to submit marketing for an “advisory review” by regulators.
Comments are taken “under advisement and (Allergan) will make necessary revisions to materials to remove any ambiguity,” the company said.
Allergan said it is working to address the FDA’s concerns about the promotion of Latisse. The company said it made changes to its Web site, among other things.
Since there isn’t a widespread precedent set for how to handle medical cosmetic ads, both Allergan and the FDA are working to establish boundaries, the company said.
