Now, after anticipating changes that were hoped to be as broad
as the landmark 1997 FDA guidelines regarding direct-to-consumer
broadcast advertising of prescription drugs, the industry is
preparing for little movement from the status quo when it comes to
Twice in February 2011, Tom Abrams, the head of FDA's Division
of Drug Marketing, Advertising and Communications, suggested that
little will change. On Feb. 8, speaking at the ePharma Summit in
New York, Mr. Abrams conceded that the process is "taking longer
than we thought," but added, "We owe it to you to get this right,"
according to Medical Marketing & Media.
But part of the delay, he said, was concern on the part of FDA
that social-media platforms such as Twitter and Facebook would not
be around in the future. "We did not want the guidances to become
quickly outdated," Mr. Abrams said.
On Feb. 22, speaking at the Drug Information Association's
annual marketing meeting in Washington, D.C., Mr. Abrams said,
"There will be guidance on some specific matters, but there will be
no new regulations or new standards. Look at our recent Warning
Letters involving social media, such as Facebook. These Warning
Letters cite existing rules and do not make new policy."
"We took it as Tom Abrams saying there's going to be some
social-media guidance but it's not going to change the rules," John
Kamp, director of the Coalition for Healthcare Communication, told
Advertising Age. "This is going to be a pretty serious
disappointment to pharma companies hoping there would be some kind
of change in DDMAC's attitude."
"The problem," said one health-care ad-agency president, who
asked not to be identified, "is that the digital space is so vastly
different from traditional 30-second spot advertising that the
[current] guidelines don't apply online. There needs to be
significant change, and it doesn't appear there's going to be."
Mr. Kamp and other industry members said there is additional
regulatory concern to Big Pharma pending this year:
- The FDA still has to issue guidance and rules stemming from the
2007 FDA Amendments Act, which gives the FDA authority to levy
monetary fines for ads that violate DTC guidelines. The act also
includes a provision that requires drug makers to submit TV ads for
pre-approval 45 days before air date. Mr. Abrams said the agency
will issue guidance on what drug categories and what kind of TV ads
will require pre-submission.
- Mr. Kamp was especially concerned about a proposed Maryland law
that would bar gifts from pharma companies to health-care
providers. The proposal was initiated by former FDA associate
commissioner-turned-Maryland Secretary of Health and Hygiene Dr.
Josh Sharfstein in the wake of allegations against a cardiologist
accused of being "indirectly influenced" by Abbott Laboratories to
perform unnecessary procedures using the company's stents. The
concern is that the bill is too broad -- it wants to ban all gifts
and payments from pharma companies to health-care providers. Even
PhRMA got in on this, releasing a statement that respectfully
opposes the legislation because it "places unnecessary restrictions
on industry-provider communications that could negatively impact
patient health and access to new pharmaceutical and health-care
innovations; and creates unnecessary and duplicative regulatory
burdens on an industry already in compliance with strict
industry-wide guidelines and federal law, which may have a negative
effect on Maryland's economy."
- Dan Jaffe, exec VP-government relations for the Association of
National Advertisers, said his group will be closely watching the
proposed FDA "clear, conspicuous and neutral" rule, which would
establish standards for how the risk information in TV and radio
ads will be presented.
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CORRECTION: An earlier
version of this story identified Dan Jaffe as exec VP-government
relations for the 4A's. He is exec VP-government relations for the