August, 19 2015, 09:45am EDT

FDA's Big Mistake: Expect Flibanserin to Be Pulled From the Market in a Few Years
Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group
WASHINGTON
The U.S. Food and Drug Administration's (FDA's) decision to approve flibanserin as a treatment for women with hypoactive sexual desire presents serious dangers to women, with little benefit, and recklessly disregards the worrisome risk information in the agency's briefing package to the advisory committees that met on June 4 to review the drug.
It would not be surprising that after enough women have been seriously harmed by the "irreversible, or life threatening injuries" about which the FDA is concerned, flibanserin will have to be taken off the market. It is unconscionable that the FDA does not have the courage to prevent such damage from a drug with such a high ratio of risks to benefits.
The FDA's analysis showed that women using the drug had an average of only half to one more "satisfying sexual encounter" every month compared to those using a placebo.
Meanwhile, the FDA's list of serious risks includes abnormally low blood pressure and fainting. The agency noted that these could be experienced when flibanserin is taken alone or with alcohol, and that these side effects "can result in serious, irreversible, or life threatening injuries."
The agency also noted that a study showed taking the drug with alcohol consumed over 10 minutes led to drowsiness, low blood pressure when standing up, and fainting. Although the study subjects were predominantly male (23 of 25 subjects), the FDA stated that "[t]he effect of the combination of flibanserin and ethanol may be more pronounced in females."
The FDA noted the difficulty of preventing alcohol use in women using the drug, saying that limits on such prevention would exist even with the implementation of a type of risk management plan intended to ensure that the benefits of prescription drugs outweigh their risks.
Unfortunately, we haven't heard the last of this drug. Expect future news to include stories of women who are harmed needlessly by flibanserin and the eventual agency call for the manufacturer to pull it from pharmacy shelves.
Public Citizen is a nonprofit consumer advocacy organization that champions the public interest in the halls of power. We defend democracy, resist corporate power and work to ensure that government works for the people - not for big corporations. Founded in 1971, we now have 500,000 members and supporters throughout the country.
(202) 588-1000LATEST NEWS
Senate Tosses 'Dangerous Provision' Preventing State-Level AI Regulation From GOP Megabill
"From the start, this provision had Big Tech's money and lobbyists all over it. This is a major victory for the American people over the AI industry," said one advocate.
Jul 01, 2025
With a 99-1 vote early Tuesday, the Republican-controlled Senate decided to remove a controversial provision that would have prevented state-level regulation on artificial intelligence for 10 years from U.S. President Donald Trump's massive tax and spending bill that is currently being debated in Congress.
Sen. Thom Tillis (R-N.C.) was the lone lawmaker who voted to keep the moratorium in the bill.
While far from the only controversial part of the reconciliation package, the provision drew opposition from an ideologically diverse group that included Democratic and Republican state attorneys general; over 140 groups working to support children's online safety, consumer protections, and responsible innovation; and faith leaders.
Senators struck Sen. Ted Cruz's (R-Texas) AI measure from the megabill by adopting an amendment introduced by Sen. Marsha Blackburn (R-Tenn.). They voted on Blackburn's amendment during a session known as a vote-a-rama. Blackburn introduced the amendment after considering an agreement that would have watered down the provision.
According to The Verge, the measure that was rejected on Tuesday required states to avoid regulation AI and "automated decision systems" if they wanted to get funding for their broadband programs.
The provision would have been a major win for Big Tech, which has made the case that state laws around AI are obstructing their ability to do business.
Advocates and Democratic lawmakers cheered the decision to strip the provision.
"From the start, this provision had Big Tech's money and lobbyists all over it. This is a major victory for the American people over the AI industry. It shows that Americans are aware of the proliferation of AI harms in real time," said J.B. Branch, Big Tech accountability advocate at the watchdog group Public Citizen.
Sen. Edward Markey (D-Mass.) said Tuesday that "early this morning, the Senate overwhelmingly voted to reject a dangerous provision to block states from regulating artificial intelligence, including protecting kids online. This 99-1 vote sent a clear message that Congress will not sell out our kids and local communities in order to pad the pockets of Big Tech billionaires."
In addition to concerns focused on Big Tech, experts recently told The Guardian that in the absence of state-level AI regulation, untrammeled growth of AI would take a toll on the world's "dangerously overheating climate."
Sacha Haworth, the executive director of the Tech Oversight Project, credited the "massive" defeat of Cruz's provision to the "incredible mobilizing by advocates to beat back Big Tech lobbying and last-minute bullying."
Keep ReadingShow Less
Critics Shred JD Vance as He Shrugs Off Millions of Americans Losing Medicaid as 'Minutiae'
"What happened to you J.D. Vance—author of Hillbilly Elegy—now shrugging off Medicaid cuts that will close rural hospitals and kick millions off healthcare as 'minutiae?'" asked Rep. Ro Khanna (D-Calif.).
Jul 01, 2025
Vice President J.D. Vance took heat from critics this week when he downplayed legislation that would result in millions of Americans losing Medicaid coverage as mere "minutiae."
Writing on X, Vance defended the budget megabill that's currently being pushed through the United States Senate by arguing that it will massively increase funding to Immigration and Customs Enforcement, which he deemed to be a necessary component of carrying out the Trump administration's mass deportation operation.
"The thing that will bankrupt this country more than any other policy is flooding the country with illegal immigration and then giving those migrants generous benefits," wrote Vance. "The [One Big Beautiful Bill] fixes this problem. And therefore it must pass."
He then added that "everything else—the CBO score, the proper baseline, the minutiae of the Medicaid policy—is immaterial compared to the ICE money and immigration enforcement provisions."
It was this line that drew the ire of many critics, as the Congressional Budget Office has estimated that the Senate version of the budget bill would slash spending on Medicaid and the Children's Health Insurance Program by more than $1 trillion over a ten-year-period, which would result in more than 10 million people losing their coverage. Additionally, Sen. Rick Scott (R-Fla.) has proposed an amendment that would roll back the expansion of Medicaid under the 2010 Affordable Care Act, which would likely kick millions more off of the program.
Many congressional Democrats were quick to pounce on Vance for what they said were callous comments about a vital government program.
"So if the only thing that matters is immigration... why didn't you support the bipartisan Lankford-Murphy bill that tackled immigration far better than your Ugly Bill?" asked Rep. Daniel Goldman (D-N.Y.). "And it didn't have 'minutiae' that will kick 12m+ Americans off healthcare or raise the debt by $4tn."
"What happened to you J.D. Vance—author of Hillbilly Elegy—now shrugging off Medicaid cuts that will close rural hospitals and kick millions off healthcare as 'minutiae?'" asked Rep. Ro Khanna (D-Calif.).
Veteran healthcare reporter Jonathan Cohn put some numbers behind the policies that are being minimized by the vice president.
"11.8M projected to lose health insurance," he wrote. "Clinics and hospitals taking a hit, especially in rural areas. Low-income seniors facing higher costs. 'Minutiae.'"
Activist Leah Greenberg, the co-chair of progressive organizing group Indivisible, zeroed in on Vance's emphasis on ramping up ICE's funding as particularly problematic.
"They are just coming right out and saying they want an exponential increase in $$$ so they can build their own personal Gestapo," she warned.
Washington Post global affairs columnist Ishaan Tharoor also found himself disturbed by the sheer size of the funding increase for ICE that Vance is demanding and he observed that "nothing matters more apparently than giving ICE a bigger budget than the militaries of virtually every European country."
Keep ReadingShow Less
'Heinrich Should Be Ashamed': Lone Senate Dem Helps GOP Deliver Big Pharma Win
The provision, part of the Senate budget bill, was described as "a blatant giveaway to the pharmaceutical industry that would keep drug prices high for patients while draining $5 billion in taxpayer dollars."
Jul 01, 2025
The deep-pocketed and powerful pharmaceutical industry notched a significant victory on Monday when the Senate parliamentarian ruled that a bill described by critics as a handout to drug corporations can be included in the Republican reconciliation package, which could become law as soon as this week.
The legislation, titled the Optimizing Research Progress Hope and New (ORPHAN) Cures Act, would exempt drugs that treat more than one rare disease from Medicare's drug-price negotiation program, allowing pharmaceutical companies to charge exorbitant prices for life-saving medications in a purported effort to encourage innovation. (Medications developed to treat rare diseases are known as "orphan drugs.")
The consumer advocacy group Public Citizen observed that if the legislation were already in effect, Medicare "would have been barred from negotiating lower prices for important treatments like cancer drugs Imbruvica, Calquence, and Pomalyst."
Among the bill's leading supporters is Sen. Martin Heinrich (D-N.M.), whose spokesperson announced the parliamentarian's decision to allow the measure in the reconciliation package after previously advising that it be excluded. Heinrich is listed as the legislation's only co-sponsor in the Senate, alongside lead sponsor Sen. John Barrasso (R-Wyo.).
"Sen. Heinrich should be ashamed of prioritizing drug corporation profits over lower medicine prices for seniors and people with disabilities," Steve Knievel, access to medicines advocate at Public Citizen, said in a statement Monday. "Patients and consumers breathed a sigh of relief when the Senate parliamentarian stripped the proposal from Republicans' Big Ugly Betrayal, so it comes as a gut punch to hear that Sen. Heinrich welcomed the reversal and continued to champion a proposal that will transfer billions from taxpayers to Big Pharma."
"People across the country are demanding lower drug prices and for Medicare drug price negotiations to be expanded, not restricted," Knievel added. "Sen. Heinrich should apologize to his constituents and start listening to them instead of drug corporation lobbyists."
The Biotechnology Innovation Organization, a lobbying group whose members include pharmaceutical companies, has publicly endorsed and promoted the legislation, urging lawmakers to pass it "as soon as possible."
"This is a blatant giveaway to the pharmaceutical industry that would keep drug prices high for patients."
The nonpartisan Congressional Budget Office has estimated that the ORPHAN Cures Act would cost U.S. taxpayers around $5 billion over the next decade.
Merith Basey, executive director of Patients For Affordable Drugs Now, said that "patients are infuriated to see the Senate cave to Big Pharma by reviving the ORPHAN Cures Act at the eleventh hour."
"This is a blatant giveaway to the pharmaceutical industry that would keep drug prices high for patients while draining $5 billion in taxpayer dollars," said Basey. "We call on lawmakers to remove this unnecessary provision immediately and stand with an overwhelming majority of Americans who want the Medicare Negotiation program to go further. Medicare negotiation will deliver huge savings for seniors and taxpayers; this bill would undermine that progress."
Keep ReadingShow Less
Most Popular