美女免费一级视频在线观看

While the Food and Drug Administration (FDA) has been relatively quiet since it announced its memorandum on pharma direct-to-consumer (DTC) ads several weeks ago, its overarching goal of limiting pharma ads is not going away anytime soon.

Industry consensus believes that the agency is preparing to take its next steps, which will likely be met by a series of industry lawsuits to challenge them, experts said.

“I would be surprised if there are no legal challenges to this whole package of initiatives that the agency is undertaking,” said Craig Bleifer, a partner at law firm McGuireWoods who previously worked as general counsel for Novo Nordisk and Daiichi Sankyo.

Some of those legal challenges could be launched against the numerous Untitled and Warning Letters that the FDA issued to drugmakers this month over “misleading” advertisements; or they could attack the agency’s efforts to withdraw the adequate provision rule, which loosened restrictions on pharma ads back in 1997.

The legal challenges would likely be centered around the First Amendment and commercial free speech, a law that legal and regulatory experts frequently cited as a major impediment to the U.S. government’s plans to crack down on DTC advertising beyond its current purview.

For one, the most extreme scenario — an outright ban on pharma DTC advertising — would likely not hold up under the First Amendment, Bleifer noted.

“Despite the administration’s talk — meaning the very negative talk about DTC ads — they haven’t actually taken a regulatory or legal step to try to ban it; they’re just making it more difficult [for drugmakers to advertise],” he said.

Pharma companies can expect to see the FDA take more steps to restrict DTC ads in some way or another in the coming months, whether they seek to enforce the letters, withdraw the adequate provision rule or craft an entirely new rule. But it might be difficult for the agency to succeed in those efforts given the potential legal complications.

The FDA’s regulatory power in enforcing letters

The first tangible action the agency has taken in its DTC advertising crusade is its Untitled and Warning Letters to pharma companies. On the same day that President Donald Trump announced the memorandum, the FDA published 40 Untitled Letters and 70 Warning Letters to various companies — including AstraZeneca, Bristol Myers Squibb, Eli Lilly and others — that their ads for certain drugs were “false or misleading.” 

Many of those letters zeroed in on the “major statement” portion of the ads, the section in which TV ads are required to state a drug’s most significant risks. In some letters, the FDA claimed that the ad’s major statement did not fully communicate the drug’s risks or minimized them. In others, the agency argued that certain visuals or music competed with viewers’ attention during the major statement.

The sheer number of letters released at one time is unprecedented, according to Suzanna Boyle, who previously served as regulatory counsel at the FDA’s Office of Prescription Drug Promotion (OPDP) before she was laid off amid the administration’s staffing cuts.

But she noted that the letters themselves are more of a threat than a rule — and in the past, the FDA typically did not take action to enforce such letters. During her tenure at OPDP, pharma companies frequently complied with the agency’s requests in letters voluntarily, “because there was a general understanding — kind of like a gentleman’s handshake — that what they’re getting in return was the ability to promote [their drugs],” Boyle said.

Historically, the FDA issued significantly fewer Untitled and Warning Letters to pharma companies because the agency’s requests to pull or change ads would have to be significantly substantiated; they would have to be prepared to prove in court that the ads were a violation of an FDA rule.

“We had to make sure everything sat comfortably on legal and regulatory grounds, because we knew First Amendment claims and lawsuits were waiting,” Boyle said. “Our job was to protect the office.”

“I don’t know that the office had ever [previously] sent out a Warning Letter that wasn’t really solid,” she added. “I don’t know how solid these letters are.”

Bleifer agreed that the FDA’s letters aren’t the end of the process, and that the agency would have to take numerous other steps in order to legally prohibit an ad from being run on TV through an order of court. Much of that also depends on how the companies respond to the letters.

“Each of them will most likely send a response to the FDA in quite a bit of detail, either going along with what FDA has to say, or making some compromise changes — or saying, ‘We’ll see you in court,’” Bleifer said. “We just don’t know what it’s going to be yet.”

Removal of adequate provision

The FDA has a different lever to pull if it wants to try to diminish DTC advertising. It could move to eliminate the adequate provision rule. Before adequate provision was proposed in 1997 and finalized in 1999, pharma broadcast ads had to state full boxed warnings, contraindications and risks — often leading to minutes-long narration.

The adequate provision guidance made it a little easier for drugmakers to advertise, allowing them to list only the most important risk information in a radio or TV ad — as long as they directed viewers to a healthcare provider, a telephone number or a website to find the full drug information. That includes having a major statement in the TV or radio ad, which highlights those most important risks.

In 2007, Congress further clarified this in a Federal Food, Drug, and Cosmetic Act (FDCA) amendment that requires the major statement be presented in a “clear, conspicuous and neutral” manner.

The Department of Health and Human Services (HHS) has stated it plans to remove the adequate provision rule and “return to the status quo policy pre-1997,” which would underscore “the core government interests of protecting the public from deception and protecting public health.” HHS argued that this action would not unduly burden advertisers and that it would preserve their right to commercial free speech.

But a rulemaking process to withdraw adequate provision could take months and even up to a year, given that it must go through several layers of approval, receive public comments, and would likely be weighed down by lawsuits.

What legal routes might the pharma industry take?

Most of the FDA’s proposed actions under its new initiative raise First Amendment concerns, and this will likely be the main argument drugmakers rely on in legal challenges, according to Michael Shumsky, a director at Hyman, Phelps & McNamara.

The Supreme Court’s precedent on commercial speech relies on a 1980 case called Central Hudson, which established that the government can regulate commercial speech if it has a substantial interest that is directly advanced by the regulation.

Central Hudson developed a four part “test” to determine whether such regulation is constitutional: The commercial speech must not be misleading; the government must have a substantial interest in regulating the speech; the regulation must directly advance the government’s interest; and the regulation cannot be more extensive than necessary.

In court, the government would have to justify that restricting pharma DTC ads advances its interest in protecting public health. But the restriction is something that drugmakers could argue does the opposite — and that pharma ads have benefits for public health.

While the Supreme Court has historically relied on Central Hudson in First Amendment cases, and has often sided with companies over the government, that is changing in lower courts. Shumsky noted that this area of jurisprudence has been in flux for the better part of the decade, with lower courts divided on what the appropriate legal standard is for commercial speech challenges. Because of these nuances, it’s difficult to predict how such lawsuits would play out.

“It’s possible that litigation challenging an FDA enforcement action could make new First Amendment case law by leading the Supreme Court to resolve some of the split in authority among the lower appellate courts,” Shumsky explained.

Beyond commercial free speech, there may be other legal strategies pharma companies could take. If the FDA succeeds in withdrawing the adequate provision rule or drafting a new rule entirely, companies might launch legal attacks based on how the agency followed the rulemaking process. There might also be an argument on some constitutional grounds, Bleifer said, if the administration takes steps to make advertising impossible or too difficult. 

Potential compromises

At the end of the day, there’s also always the possibility that the administration might draw a hard line in talk — but seek to negotiate a middle ground with drugmakers to avoid significant litigation. 

“[It depends] on how much resources FDA puts behind it or whether the administration sees all of the litigation like they did in the ‘80s and ‘90s and pulls back,” Bleifer said. “They might be willing to compromise and come to some new equilibrium that we haven’t yet invented.”

He pointed to the Trump administration’s supposed crackdown on drug pricing and how the White House appears to be willing to negotiate with pharma companies to some extent on any new drug pricing reform policy.

Lucy Rose, a pharma consultant who served as director at the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) — which is now OPDP — in the 1990s, wrote in a LinkedIn post that she believes the FDA crackdown is an opportunity for the pharma industry to “create something positive as a result” and even improve public trust.

“I suggest the industry see this as an opportunity to lean in to provide as much safety as possible, and to do so in a way that makes it even easier to access,” she wrote. She added that one idea is adding a QR code to each TV ad that provides immediate access to the full prescribing information. 

Either way, pharma marketers should still be closely examining some of their DTC ad practices as they wait for next steps. While much of the FDA’s letters and statements have focused on TV ads, Bleifer pointed out that the agency’s initiative could also go beyond TV and touch pharma advertising on social media.

As part of the effort, the FDA said it plans to “close digital loopholes” by expanding its oversight across all social media, including influencers partnerships, “dark ads,” AI-generated content and chatbot interactions.

“That’s an area where companies should be paying attention, taking a second look at their approach and making sure their messages are truthful and not misleading,” Bleifer said.