In letters to the Food and Drug Administration and the Federal Trade Commission, Center for Science in the Public Interest reported that its tests of eight products marketed online as addressing the symptoms of opioid withdrawal showed the as were “riddled with pseudo-scientific jargon and frighteningly ill-informed.” CSPI urged the FDA to issue immediate warning letters and bring enforcement action that required “cessation of these sales and other such products and allow inspectors to seize products.” It also asked the two agencies to work together to ensure that these companies will not be able to mislead consumers and profit from bogus claims.
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.
Last week, at a Hilton hotel in a Maryland suburb near Washington, D.C., reports The New Republic, the Food and Drug Administration held a little-noticed public meeting with big implications for anyone who goes grocery shopping in America. Food industry representatives, consumer advocates, and nutrition experts spent the day trying to influence the government as it looks to redefine which foods are allowed to be labeled as “healthy.” Kristin Reimers, nutrition director for the packaged food company Conagra Brands, told the crowd she’s all for encouraging healthier foods, but added, “It’s important to keep in mind that taste is the primary factor that drives consumers to the foods they buy.” In an interview, she clarified that she thinks there should be a bit more sodium, saturated fat, and sugar permitted in “healthy” foods than the FDA currently allows.
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.
CNBC reports that the Food and Drug Administration announced last week that it is extending the feedback period for comments about use of the word “healthy” on food packaging. The move gives the food industry and consumer groups more time to weigh in on whether the government should redefine the meaning of “healthy” on food labels. But it also gives the incoming Trump administration more time to review the issue, and could ultimately lead to reforms in the way the government comes up with food and labeling guidelines.
“Patient advocacy” groups have a unique power on Capitol Hill, writes David Dayen in The Intercept. They claim to represent the true voice of constituents, untainted by special interest bias. Politicians and the Food and Drug Administration use their endorsements as reflective of genuine public support. But a new study shows that nearly all of these patient advocacy groups are captured by the drug industry. David Hilzenrath at the Project on Government Oversight (POGO) reports that at least 39 of 42 patient advocacy groups who participated in discussions with the FDA over agency review processes for prescription drugs received funding from pharmaceutical companies. And at least 15 have representatives of drug or biotechnology companies on their governing boards. The study is particularly notable now because Congress is poised to pass the 21st Century Cures Act, which trades temporary additional funding for the National Institutes of Health and the FDA for permanent weakening of the FDA’s approval process. Over 1,400 lobbyists have been working on this bill, which would be a major financial boon to the drug and medical device industries.
In Salon, Martha Rosenberg writes that it is hard to believe only four senators opposed the confirmation of Robert Califf, who was approved today as the next FDA commissioner. Vocal opponent Bernie Sanders condemned the vote from the campaign trail. But where was Dick Durbin? Where were all the lawmakers who say they care about industry and Wall Street profiteers making money at the expense of public health? Califf, chancellor of clinical and translational research at Duke University until recently, received money from 23 drug companies including the giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK according to a disclosure statement on the website of Duke Clinical Research Institute.
A new national poll shows that most Americans believe electronic cigarettes are harmful to people’s health. The findings could bolster the Food and Drug Administration as it moves to regulate e-cigarettes for the first time.