In a commentary in the New England Journal of Medicine, Robin Feldman and Connie Wang write that pharmaceutical companies have become adept at converting regulatory pathways into vehicles for profit-boosting strategies. They study the “citizen-petition process” that the Food and Drug Administration implemented in the 1970s to give the average citizen a way to voice concerns. Using 12 years of FDA data, they found that the “concerned citizen” is frequently a drug company raising frivolous or questionable claims in a last-ditch effort to hold off competition.
The Food and Drug Administration’s approach to consumer protection faces a potential turning point when a Senate committee takes up President Trump’s nomination of Scott Gottlieb to head the agency, writes POGO, the nonprofit Project on Government Oversight. Trump has called for slashing FDA restraints on pharmaceuticals, and with Gottlieb’s appointment he would entrust the task to a doctor and former FDA official who has been immersed in the pharmaceutical industry. One of The FDA’s main missions is making sure that prescription medicines sold to the public are safe and effective. The FDA gets much of its funding through so-called “user fees” paid by pharmaceutical and medical device companies, and the money comes with strings attached, giving industry extraordinary leverage over its federal overseer. In Gottlieb, Trump has chosen a potential FDA commissioner whose financial disclosures list line after line of payments from drug and biotech companies.
The Pharmaceutical Research and Manufacturers of America has begun running television ads in New York criticizing Gov. Andrew Cuomo’s proposed new state controls over drug prices, reports the Wall Street Journal. Airing in several upstate counties, the ads describe Cuomo’s proposal and similar legislation put forth by the New York State Assembly’s Democratic majority as a tax from “New York City politicians” that would raise out-of-pocket costs and weaken health care quality. “Tell your legislators to reject the tax on prescription drugs,” a narrator states in the ads. The ads are said to be partly intended to pressure Republicans, who run the state Senate, to keep the measure out of the budget. Cuomo’s office disputed that his plan would increase out-of-pocket costs or weaken the quality of care. His plan seeks to cap drug prices through a series of state measures. He proposed creating a price ceiling for drugs that are reimbursed under Medicaid, imposing a surcharge on companies that exceed state price recommendations, and tightening regulations on intermediary brokers who negotiate drug prices for insurance plans
A new report analyzes the complex ways in which Belgian magazines deal with health information on the pharmaceutical industry supplied by PR practitioners. Based on content analysis of health items in a representative sample of magazines and interviews with magazine health journalists and their editors, the authors found that academic and medical experts were the most important sources for journalists. While the researchers found few explicit references to pharmaceutical industry sources, the interviews suggest that pharmaceutical PR creeps into health coverage in a more indirect and much more sophisticated manner, for instance by offering additional services such as contacts with scientists or patients. The authors concluded that the influence of pharmaceutical PR in magazine health news is stronger than would be expected based solely on quantitative analyses of editorial content.
Full citation: De Dobbelaer R , Van Leuven S, Raeymaeckers K. Dirty dancing: Health journalists and the pharmaceutical industry a multi-method study on the impact of pharma PR on magazine health. Public Relations Review (2017), http://dx.doi.org/10.1016/j.pubrev.2017.02.002
As it readies for battle with President Donald Trump over drug prices, writes Pacific Standard, the pharmaceutical industry is deploying economists and health-care experts from the nation’s top universities. In scholarly articles, blogs, and conferences, they lend their prestige to the lobbying blitz, without always disclosing their corporate ties. Over the last three years, pharmaceutical companies have mounted a public relations blitz to tout new cures for the hepatitis C virus and persuade insurers, including government programs such as Medicare and Medicaid, to cover the costs. That isn’t an easy sell, because the price of the treatments ranges from $40,000 to $94,000 — or, because the treatments take three months, as much as $1,000 per day.
Big Pharma is striking back at Gov. Cuomo’s proposal to control the price of prescription drugs, reports the New York Daily News. The Pharmaceutical Research and Manufacturers of America is set to launch a new campaign on Wednesday calling on state lawmakers to reject Cuomo’s plan, saying it will do nothing to improve patient access to needed prescription drugs while threatening research and development and New York jobs. The “Prescribe Real Solutions” campaign will include online ads, a new website and a series of events across the state urging New Yorkers to contact their legislators, those close to the effort say. State of Politics, meanwhile reports that Gov. Cuomo’s top health officials told state lawmakers that price control regulations will withstand legal challenges.
President Trump met with leaders of some of the world’s biggest pharmaceutical companies Tuesday and emphasized the need to lower “astronomical” drug prices, decrease regulations and bring more drug manufacturing into the United States, reports The Washington Post. Trump offered no specific policies, but mentioned increasing competition and “bidding wars” as a way to bring down prices. In the past, he has lashed out at the pharmaceutical industry for “getting away with murder” and threatened to use the government’s bargaining power to force down drug prices for programs like Medicare.
Public Citizen Response
In a response to this proposal, Michael Carome, Director of Public Citizen’s Health Research Group wrote:
President Donald Trump’s preposterous promise to pharmaceutical company CEOs to slash U.S. Food and Drug Administration (FDA) regulations by 75 to 80 percent would, if fulfilled, fundamentally destroy the ability of the agency to protect patients and consumers from unsafe or ineffective medications and medical devices, hazardous foods and dietary supplements, and dangerous tobacco products, among other things. The end result would be countless preventable deaths, injuries and illnesses across the U.S. Trump’s horrifying proposal reflects utter ignorance about the FDA’s essential role in protecting public health and once again demonstrates his commitment to placing corporate profits above protecting the safety of the American people.