WASHINGTON, Sept 9 (Reuters) - The U.S. Food and Drug
Administration will send out around 100 cease-and-desist
enforcement notices and thousands of letters warning
pharmaceutical companies that direct-to-consumer ads must comply
with regulations that are already on the books, senior
administration officials said on Tuesday.
The FDA plans to enforce regulations stipulating that drug
ads not create a misleading impression about the products and
appropriately disclose side effects, the officials said.
"There are ads that are clearly crossing the line with
respect to the regulation, making any potential future legal
action, I think, pretty clear cut," one of the officials said.
U.S. President Donald Trump also signed a presidential
memorandum on Tuesday afternoon, the White House said, calling
on his administration to step up enforcement of
direct-to-consumer pharmaceutical ads in order to ensure
transparency and accuracy.
"The Secretary of Health and Human Services shall
therefore take appropriate action to ensure transparency and
accuracy in direct-to-consumer prescription drug advertising,"
the memorandum said.
The presidential action and FDA letters coincide with
the release of the report on U.S. children's health by U.S.
Health Secretary Robert F. Kennedy Jr.'s Make America Healthy
Again Commission.
The officials said that enforcement of drug ads has been
increasingly lax, adding that last year, the FDA did not send
out any enforcement letters about drug advertising.
They did not disclose which companies had been sent the
enforcement or warning letters. They said they were not only
concerned about ads from drugmakers, but also ads from online
pharmacies "that are not following the same rules that many
pharmaceutical companies follow."
The government is also examining the role social media
influencers play in advertising drugs and plans to close a
loophole that allows companies to refer patients to a website
for information on side effects, the officials said.
Administration officials said there are no additional
presidential actions planned on direct-to-consumer drug ads,
calling the memorandum "the strongest, boldest action that we
can take on making sure that patients have adequate safety
information."
In his first term, Trump attempted to push through a rule
that would have forced pharmaceutical companies to include the
wholesale prices of their drugs in television advertising.
U.S. courts sided with drugmakers Merck ( MRK ), Eli Lilly ( LLY )
and Amgen ( AMGN ) and struck down the rule.
U.S. pharmaceutical lobby group PhRMA said its member
companies "are committed to responsible advertising, and we look
forward to learning more details about the policy changes
announced today."