A web of counterfeit abortion pills awaits

From: POLITICO Pulse - Monday Aug 01,2022 02:26 pm
Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
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WELCOME TO MONDAY PULSE Yes, it’s Monday, but there might be some hope for Choco Taco fans. If you could bring back one discontinued food or drink, what would it be? Send thoughts and tips to bleonard@politico.com or tomorrow’s author, Tucker, at tdoherty@politico.com .

 

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Did you know the majority of cancer R&D takes place after the initial approval of a medicine? For example, an FDA approved treatment for skin cancer has since been approved for use in treating roughly 20 additional types of cancer, including for use earlier in treatment for many cancers in adults and children. There is a better way to lower costs without risking new medicines. Government price setting jeopardizes this critical innovation. Learn more.

 
Driving the Day

ROGUE PHARMACIES AND ABORTION PILLS — A quick Google search might take you to counterfeit abortion pills, POLITICO’s Ruth Reader reports .

Search “buy Cytotec online cheap,” for example, and the first four Google results are sites that illegally offer to ship the abortion pills sans prescription. Even though the Supreme Court’s June decision turned abortion rights over to the states, medication abortion is still a possibility even in states that restrict or ban abortion, whether via telemedicine or crossing state lines.

The jumble of state laws is fertile ground for scammers looking to make a buck off people seeing abortions, posing a public health threat that’s likely to grow as more states ban or restrict abortion, public health experts told POLITICO.

“Anytime you create a fractured health care system or fractured supply chain, that confusion is going to be taken advantage of by criminals,” said John B. Hertig, an associate professor of pharmacy practice at the Butler University College of Pharmacy and Health Sciences.

Patients might get real pills, but the rogue online pharmacies sometimes sell counterfeit or expired drugs, fail to fill orders or steal payment information. And the government has limited authority to step in.

The Food and Drug Administration doesn’t have subpoena power to unmask those behind the websites. Google says it usually can’t tell when sites break the law but take them down from search results when the government asks.

Before the court’s decision and outside the context of abortion medication, the FDA has pushed tech companies to help crack down on the bad actors as Americans increasingly look to the web to find drugs. Ninety-five percent of the about 35,000 online pharmacies worldwide are operating illegally, according to the National Association of Boards of Pharmacy.

 

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President Joe Biden listens as Treasury Secretary JanetYellen speaks.

Biden wasn't masked in public events at the end of last week. | Susan Walsh/AP Photo

BIDEN’S REBOUND COVID President Joe Biden tested positive again for Covid-19 on Saturday and Sunday morning, experiencing a rebound after taking Paxlovid.

As of Sunday, he “continues to feel well” and will isolate from the White House, according to a letter from White House doctor Kevin O’Connor.

Biden had returned from isolation on Wednesday after finishing his five-day course of Pfizer’s antiviral therapy. He wasn’t masked in public events at the end of the week, going against CDC guidance, though White House press secretary Karine Jean-Pierre said he was compliant because he was more than six feet from others.

As our Katherine Ellen Foley and David Lim report , Biden’s rebound is a phenomenon that’s happened for some people after taking a course of Paxlovid.

“This happens with a small minority of folks,” Biden tweeted Saturday. “I’ve got no symptoms but I am going to isolate for the safety of everyone around me. I’m still at work, and will be back on the road soon.”

The CDC has issued a health advisory about symptom recurrence and said that rebound cases haven’t been severe. The agency said no evidence supports the need for a second course of Paxlovid.

On the Hill

MANCHIN TO SINEMA: GET ON BOARD Sen. Joe Manchin (D-W.Va.) took to Sunday shows to push for his party-line spending bill, calling on fellow Democrat Krysten Sinema of Arizona to support it, POLITICO’s Burgess Everett reports .

Manchin’s case: The deal includes Sinema’s “tremendous input,” doesn’t hike taxes and is an “all-American bill.”

“Kyrsten Sinema is a friend of mine, and we work very close together. She has a tremendous, tremendous input in this legislation,” Manchin said on NBC’s Meet the Press. “She basically insisted [on] no tax increases; [we’ve] done that. And she was very, very adamant about that; I agree with her. She was also very instrumental on prescription drug reform.”

Last year, Manchin and Sinema had for months been in line with reducing Democrats’ spending plans, and Sinema had worked on the prescription drug portion before Manchin rejected the package — then known as Build Back Better.

Now: Sinema was caught off guard by Manchin and Senate Majority Leader Chuck Schumer’s announcement last week that they had a deal, especially with regards to the so-called carried interest loophole that would bring in billions in revenue.

The deal includes Affordable Care Act expansions for three years and would allow Medicare to negotiate drug prices.

It’s yet not clear where Sinema stands. She had no new public comments Sunday but has been less inclined to change the tax code than Manchin, arguing it could stifle economic growth.

Medicaid coverage gap in the bill? The National Urban League and the Rev. Al Sharpton’s National Action Network are gunning for Schumer to include provisions to fill the Medicaid coverage gap for people in states that haven’t expanded Medicaid.

The organizations and other groups wrote to Schumer, urging him to include the issue in the package. The effort represents a last-ditch bid to address the gap.

“It would be a missed opportunity to exclude Senator Warnock’s proposal to expand the ACA to close the Medicaid coverage gap,” the organizations’ leaders wrote in a letter to Schumer obtained by POLITICO.

TOOMEY DEFENDS GOP ON VETERANS BILL —  Sen. Pat Toomey of Pennsylvania defended his move along with other Republicans to block a bill seeking to boost health care access to veterans exposed to burn pits, POLITICO’s Allie Bice reports .

The legislation — called the Honoring Our Promise to Address Comprehensive Toxics Act — would deliver benefits and health care for those veterans. It had passed the Senate 84-14 in June and came back to the chamber for a procedural vote last week, but Republicans unexpectedly blocked it.

Toomey said he wanted to make technical changes related to the accounting of VA funds. The move to block the legislation has drawn criticism from Democrats and veterans groups.

“What I’m trying to do is change a government accounting methodology that is designed to allow our Democratic colleagues to go on an unrelated $400 billion spending spree that has nothing to do with veterans and won’t be in the veterans space,” he said Sunday on CNN.

Toomey also said he’d support the bill if his amendment goes through. On CNN, Veterans Affairs Secretary Denis McDonough called Toomey’s action petty and unnecessary and said the accounting changes could hurt care.

“These folks have waited long enough. Let’s just get it done,” McDonough said. “I think they should just get on with it, have the vote.”

The Next Cures

Psilocybin mushrooms are seen in a grow room.

"We are on the cusp of a new frontier in drug legalization," Ryan Lizza wrote. | Peter Dejong, File

THE SHROOM PLAYBOOK — Psychedelic mushrooms are essentially legal in Washington, D.C., something that even a lot of locals don’t know, POLITICO’s Ryan Lizza reports .

Voters green-lit a ballot measure in 2020 that rendered growing, purchasing and distributing mushrooms the lowest priority for law enforcement. You can have mushrooms delivered in less than an hour in the district.

The VA is holding clinical trials for psilocybin, the drug in psychedelic mushrooms, for mental health issues. And the FDA is likely to approve psilocybin within the next two years, The Intercept reported this week .

Cities and states are further along than the federal government, though, with pushes in more than two dozen states to study, decriminalize or legalize psychedelics.

Colorado is at the center of the push. Voters in the state will decide in November whether the state will establish a regulated system of psilocybin treatment centers for people over 21.

“It’s safe to say we are on the cusp of a new frontier in drug legalization, and in the next few years psychedelics are going to be as easily obtainable in cities and states across the country, as they are right now in D.C. And most politicians haven’t even started to think through what their position on this issue should be,” Ryan writes.

He went to Colorado and spoke with a leader of the Colorado campaign in the latest episode of POLITICO Deep Dive .

 

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THE WEEK AHEAD

Although the House is out for August recess, the Senate remains in session. Some things to watch:

— The Senate Finance Committee is meeting at 2:30 p.m. Wednesday on “addressing organizational failures” of the country’s organ transplant and procurement network.

— A Senate Homeland Security and Governmental Affairs subcommittee is having a hearing on gain-of-function research at 2:30 p.m. Wednesday.

— FDA Commissioner Robert Califf is speaking with Health Affairs Editor-In-Chief Alan Weil at 1:30 p.m. on Wednesday.

 

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What We're Reading

Former health officials said the Biden administration’s move to give more power to the Administration for Strategic Preparedness Response in future pandemics is still "unlikely to clarify" what agencies are responsible for, Bloomberg's Shira Stein and Riley Griffin report .

The U.S.’ first polio case in close to a decade is linked to vaccine-derived viruses detected in Jerusalem and London, STAT’s Helen Branswell reports .

Washington, D.C., is expanding vaccine mandates for students, making it “among the strictest” mandate in the country, The Washington Post’s Lauren Lumpkin and Perry Stein report .

 

A message from PhRMA:

Today, there are 90 medicines in development for Alzheimer’s disease, 119 medicines for breast cancer, 26 medicines for childhood diabetes… But government price setting could mean fewer medicines in the coming years. Which diseases could go untreated if Congress passes government price setting? There is a better way to lower costs without risking new medicines.

 
 

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