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Gilead has said it will donate 2.4 million bottles per year of Truvada for PrEP to the effort, and has previously denied accusations that the negotiations to do so have any connections to patents. But on Thursday Rep. Elijah E. Cummings (D-Md.) demanded details from Gilead’s discussions with the U.S. government over the deal.
After resigning as FDA commissioner in March, Scott Gottlieb now joins the pharmaceutical industry he once regulated. In other pharma news: details emerge about House Speaker Nancy Pelosi’s drug pricing proposal; a few states explore importing drugs from outside the U.S.; the future of biologics; and more.
Louisiana will pay a flat fee for unlimited access to very expensive hepatitis C medication for five years, and will be able to treat as many people as it can, rather than pay a per-patient drug price. The deal allows the state to potentially eradicate the disease in a short time while maintaining a stable budget by spreading the cost over several years.
The bill, which Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tenn.) worked on with Sen. Patty Murray (D-Wash.), addresses a sweeping array of health care topics from prescription drugs to surprise medical bills. The package also includes a bill from Senate Majority Leader Mitch McConnell (R-Ky.) and Sen. Tim Kaine (D-Va.) to raise the age to buy tobacco from 18 to 21.
Each year in the U.S., about 17,500 women and 9,300 men get HPV-related cancer through sexual activity. Previously the vaccine was recommended only for preteen girls and boys to protect them before exposure to the virus, with catch-up vaccinations through age 26. The CDC usually accepts the recommendations of its Advisory Committee on Immunization Practices.
As many as 31 million women might have had a traumatic brain injury and 21 million might have had multiple mild ones. Yet there’s little research on the lasting effects in women. In other public health news: worker safety, burnout, genetic testing, wildfires, heart attacks, menstrual products, and anger.
The researchers looked at anticholinergic drugs that work by blocking a chemical called acetylcholine, which acts as a neurotransmitter and is involved in many nervous system functions including muscle movements, heart rate, the widening of blood vessels, respiratory functions and muscle contractions in the stomach during digestion. Previous research has found a link between the drugs and dementia, but a new study strengthens those findings.
“This is the age of blockbusters,” said David Maris, an analyst for Wells Fargo who follows the drug industry. “And when blockbusters start to go away, companies don’t have too many things they can do.” AbbVie is under pressure to diversify its portfolio and its shares have lost more than a third of their value since January 2018 over concerns as the patent expiration on Humira, its top-selling drug, approaches.
The Republicans are nervous the far-reaching proposals to limit increases in Medicare could tip-toe close to price controls for drugs, which Republicans have long opposed. Meanwhile, lawmakers in the House also debate Medicare and drug prices.
Read recent commentaries about drug-cost issues.
News outlets report on stories related to pharmaceutical pricing.
For some experts it is increasingly apparent that there is another, more disturbing reason for the tragic lack of progress being made in Alzheimer’s research. A group of researchers had been so determined that one approach would work, few tried anything else. In other pharmaceutical news: AbbVie announces $63 billion deal to acquire Allergan, an analysis finds drugmakers often commit to follow-up studies after approval but few of them are new; and more.
While experts say a prominent legal expert’s warnings over the constitutionality of legislation address surprise medical bills are weak, it is still unlikely that any new regulations will skate through without being challenged in court.
Skeptics of drugs like Vyleesi balk at the idea of a pharmaceutical product playing a role in sexual desire. To them, prescribing a drug women with low sexual drive misguidedly reduces the complexity of the condition to a biological issue. Experts say they don’t expect many women to seek the treatment as the drug can only be administered through injections.
The agency is racing to get the drug through the approval process after President Donald Trump signaled support for the treatment. But psychiatrists and medical researchers, including some at the VA, raised questions about the drug’s effectiveness and safety, and Democratic lawmakers question why the decision-making on the drug has been so rushed.
With so many counties, cities, municipalities and states in the game, everyone is vying for their equal share of the millions expected to come out of the court cases against the opioid-makers. Meanwhile, David Sackler, of Purdue Pharma notoriety, speaks out in defense of the company. In other news on the opioid epidemic: FDA’s opioid approvals, data on prescriptions, international guidelines for painkillers, and more.
Progressive lawmakers had invited Big Pharma CEOs to participate in a hearing, but as a political group and not a formal congressional committee, the Progressive Caucus has little power to compel the industry figures’ presence. The hearing, however, provided an outlet for lawmakers to signal their frustration with Democratic leadership’s approach to drug prices. Meanwhile, following a lobbying blitz, lawmakers consider dialing down bill on patents.
By contracting directly with health plans and employers, Amazon-PillPack would essentially become its own pharmacy benefit manager, which, given Amazon’s distribution capabilities, could quickly shake up the nation’s prescription drug market. Court documents in a case about personnel revealed the strategy that many in the industry fear. In other pharmaceutical news: a drug-price watchdog group with ties to pharma; Merck’s expansion into cancer treatments; and more.
Senate Finance Committee Chairman Chuck Grassley (R-Iowa) previously held his tongue on the issue, saying he was going to wait for a formal proposal from the White House. But now he says he’s “studied it long enough” to think that the plan will hurt innovation.
Politico talked to a dozen current and former White House and HHS officials, as well as others familiar with the tensions brewing between President Donald Trump’s aides and HHS Secretary Alex Azar. “You have two teams with two visions,” an individual who’s been in heated meetings with HHS and the White House told Politico. “Alex is outnumbered and keeps losing.”