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President Donald Trump listened in January to the presentation of Stephen Ubl, President and CEO of Pharmaceutical Research and Manufacturers of America, ranked second on the left, at a meeting at the White House. The exorbitant prices of some drugs are a big problem for some voters this fall.
Pool / Ron Sachs / Getty Images
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Pool / Ron Sachs / Getty Images
President Donald Trump listened in January to the presentation of Stephen Ubl, President and CEO of Pharmaceutical Research and Manufacturers of America, ranked second on the left, at a meeting at the White House. The exorbitant prices of some drugs are a big problem for some voters this fall.
Pool / Ron Sachs / Getty Images
The Trump administration announced Monday night that it would require drug manufacturers to disclose catalog prices of their drugs in television ads. The move sets the stage for months or even years of battle with the powerful industry.
The proposed rule would require pharmaceutical companies to include the price in a television advertisement for any drug costing more than $ 35 per month. The price must be indicated at the end of the advertisement in a "legible" way, indicates the rule, and must be presented on a contrasting background, so as to be easily readable.
Health and Social Services Secretary Alex Azar said that voluntary initiatives are not enough.
"We will not wait for an industry, with so many contradictory and perverse incentives, to reform itself," Azar told the public at the National Academy of Sciences, the United States, and the US. engineering and medicine in Washington, DC.
Critics point out, however, that even if approved, the proposed rule does not provide any effective mechanism for compelling companies to comply. The application would rather depend on shame: the federal regulators would publish a list of companies that break the rule. The application would also depend on the private sector to control itself in case of dispute.
"It should be noted that the government does not want to take any coercive measures," said Rachel Sachs, associate professor of law at Washington University in St. Louis and expert on drug price regulation. The rule could never be finalized, she added.
"It will take months, if not years, for this regulation to be implemented and freed from the cloud of litigation that will follow," Sachs said. "And the administration knows it."
Earlier Monday, the pharmaceutical industry group had launched an offensive in anticipation of Azar 's speech by announcing his own plans.
"Putting the catalog prices in isolation in commercials would be misleading or confusing," said Stephen Ubl, CEO of Pharmaceutical Researchers and Manufacturers of America, the leading group specializing in brand name drugs.
Instead, Ubl promised that pharmaceutical companies would direct consumers to websites containing the current price of a drug and estimates of what users can expect to pay, which can vary. considerably depending on the coverage.
Drug manufacturers will voluntarily join this release next spring, he said. Ubl, whose trade group represents the world's largest pharmaceutical companies, has strongly criticized the White House proposal.
The Trump administration's proposal comes weeks before the mid-term elections, during which health care should be a major concern for voters. Kaiser Family Foundation polls suggest that most voters favor price transparency in drug advertising. (Kaiser Health News is an independent editorial program of the foundation.)
The White House plan, mentioned in a draft policy released this summer, has been hailed by insurance groups and by the American Medical Association.
Meaning. Chuck Grassley, R-Iowa, and Dick Durbin, D-Ill., Also proposed the plan in the Senate last month, but did not get enough support. leave the Senate.
Grassley applauded Azar's announcement, saying it was "a sensible way to lower prices."
Critics of the two approaches to price transparency released on Monday highlighted a host of complications, suggesting that neither the PhRMA nor the White House approach would fully explain what consumers would actually pay for a drug ad.
Dale Cooke, a consultant who works with pharmaceutical companies to try to meet the advertising requirements of the Food and Drug Administration, warned that "there was no reason to believe that the drug". price display would help lower prices.
"Nobody ever explained why it would work," said Cooke. "What is the mechanism by which this translates into lower prices for medicines?"
Such a policy could actually confuse patients, Cooke said. "Consumers, intimidated and baffled by the highest list prices, can be deterred from contacting their doctor about drugs or health problems."
The price list of a drug – the metric system that HHS wants to emphasize – often has little bearing on what most patients pay at the pharmacy. Insurance and pharmacist managers often negotiate cheaper prices than the regular price. And patients who have health insurance usually pay only what their copay or franchise requires. Some patients qualify for further reductions.
However, some consumers might be forced to pay the full price, depending on the design of their insurance plan or the lack of health coverage.
"The system is very opaque, very complicated," said Adrienne Faerber, a lecturer at the Institute of Health Policy and Clinical Practices in Dartmouth, who conducts research on drug marketing. "And most importantly," she added, "there is no huge relationship between the price list of drugs and what patients will have to pay for themselves."
But Faerber also finds that the strategy of the industry is lacking.
According to the PhRMA plan, drug manufacturers would not have to standardize how they organize or display their price information, which, according to Faerber, could make comparisons of medicines and prices difficult for consumers .
PhRMA has also announced its partnership with patient advocacy groups to create an online "patient financial accessibility platform" that could help patients research costs and coverage options. insurance of specific drugs.
Ubl presented the industry's proposal as a way to respond more effectively to concerns about the transparency of drug prices.
Pharmaceutical manufacturers rely heavily on national advertising and together represent the third largest consumer of all sectors. in national television advertising, according to Michael Leszega, Head of Strategic Intelligence at Magna Consulting.
At certain times of the day, pharmaceutical advertising accounts for more than 40% of TV commercials, Leszega said. And these ads are distinguished by the fact that they are usually longer than other ads – with a long list of side effects and warnings that the pharmaceutical industry must score at the end.
These denials highlight another challenge for Trump administration: legal action.
The rule proposed by the White House indicates that its legal justification was based on the responsibility of the Centers for Medicare & Medicaid Services to ensure that the health coverage programs it administers – Medicare and Medicaid – are managed in a way that "minimize reasonable expenses".
However, according to Sachs, this legal argument may be weak, as most drugs are sold to a wider audience than Medicare and Medicaid recipients.
A set of Supreme Court rulings dictate how waivers and disclosures may be required, said lawyer and constitutional law expert Robert Corn-Revere, an associate researcher at the Cato Institute. He filed a "friend of the court" in a case before the US Supreme Court in 2011 regarding commercial speech and the pharmaceutical industry.
In general, the requirements of the administration must respect the standards of purely factual, non-controversial and non-binding, said Corn-Revere.
On the question of whether requiring drug prices to be mentioned in the advertisement violates the First Amendment's freedom of expression guarantee, Corn-Revere said that "everything depends on the specifics".
Ubl, questioned about the possibility of challenging in court the rule proposed by the administration, has not ruled out to take such measures.
"We believe that there are important legal and constitutional principles that stem from" the obligation of catalog price disclosure, Ubl said. "We have concerns about this approach."
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