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Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs
On a sweltering morning in western India in 2022, three U.S. inspectors showed up unannounced at a massive pharmaceutical plant surrounded by barricades and barbed wire and demanded to be let inside. For two weeks, they scrutinized humming production lines and laboratories spread across the dense industrial campus, peering over the shoulders of workers at the tablet presses, mixers and filling machines that produce dozens of generic drugs for Americans.
Much of the factory was supposed to be as sterile as an operating room. But the inspectors discovered what appeared to be metal shavings on drugmaking equipment, and records that showed vials of medication that were “blackish” from contamination had been sent to the U.S.
Quality testing in some cases had been put off for more than six months, according to their report, and raw materials tainted with unknown “extraneous matter” were used anyway, mixed into batches of drugs. Sun Pharma’s transgressions were so egregious that the U.S. Food and Drug Administration imposed one of the government’s harshest penalties: banning the factory from exporting drugs to the U.S.
RFK Jr. Wants to Crack Down on Drug Ads. That Could Cripple Some Broadcasters
For decades, pharmaceutical companies have shelled out big bucks to broadcasters to place ads between TV segments. But a pair of policies being considered by U.S. Health and Human Services Secretary Robert F. Kennedy Jr. could change that and leave broadcasters in financial straits.
While not an outright ban, the two policies would make it significantly more difficult and expensive for drug companies to push their products across broadcasters’ airwaves, according to a Bloomberg report on Tuesday. The policies look to either mandate that advertisers elaborate on the risks posed by their drugs — forcing ads to be longer and, therefore, more expensive — or bar drugmakers from writing off direct-to-consumer ads as business expenses on their taxes, also padding the bill, Bloomberg reported.
Drug ads, which are illegal in most countries, have been a hallmark of U.S television since the 1980s. By raising the bar on pharmaceutical ads, the Trump administration threatens a crucial revenue source for broadcasters.
The HPV Vaccine Can Prevent Genital Cancers, but Fewer Teens Are Getting the Jab
Christine Walters was diagnosed with advanced cervical cancer when her daughter was just a baby. “I just remember looking at her and saying, you need to buy me more time. I literally do not care what I have to do to stay alive long enough that she will remember me,” she said.
Doctors gave Christine 12 months to live. That was 10 years ago. She counts her survival to date as a “miracle”, despite not knowing how much time she has left. Cervical cancer is caused by the human papillomavirus (HPV). Had the HPV vaccine been around when Christine was young, she believes she would have avoided her cancer diagnosis.
As a secondary teacher, Christine now encourages her students to get the jab as part of the vaccine program rollout in schools. “They go, ‘but it’s a needle, Miss, it hurts’… I don’t think a lot of people see that one little needle can protect you for something so significant as a cancer,” she said. “I just tell them you are so lucky to have this available to you and without it, you could end up like me.”
Lawmakers Refresh Tax-Dodging Accusations Against Big Pharma, Targeting Pfizer, AbbVie and Others
Two Democratic lawmakers have renewed accusations that large pharma companies have evaded paying U.S. taxes through a legislative loophole that drugmakers are allegedly lobbying to retain.
In letters (PDF) published Tuesday, Sen. Elizabeth Warren, D-Mass., and Congresswoman Jan Schakowsky, D-Ill., accused AbbVie, Pfizer, Amgen, Merck & Co. and Johnson & Johnson of paying little to nothing in federal taxes since 2018 by moving intellectual property ownership and production outside the U.S. During the same period, the companies have raked in hundreds of billions of dollars in combined global profits, the lawmakers said in a press release.
The two lawmakers placed part of the blame on the 2017 Tax Cuts and Jobs Act, which they say created new incentives for pharmaceutical companies to shift the vast majority of their profits offshore. In making the argument, the two cited an article published last year by the independent nonprofit Council on Foreign Relations.
Cantor Keeps Merck at Neutral Amid Gardasil Dosage Review by ACIP.
Merck & Co., Inc. is one of the 15 best stocks to invest in for an 18 year old. On June 10, Cantor Fitzgerald reaffirmed its Neutral rating on Merck & Co., Inc. with a fixed price target of $85 per share. Carter Gould, the firm’s analyst, offered insight concerning Merck’s Gardasil vaccine, which has raised investor concerns because of possible modifications to suggested dosage schedules.
It was originally anticipated that the Advisory Committee on Immunization Practices (ACIP) would suggest a schedule of 1-2 doses of Gardasil; this recommendation could have an effect on the vaccine’s projected sales in the U.S. Although there was evident motion in this approach, Gould pointed out that the anticipated risk to Merck’s 2025 sales may be exaggerated.
He added that known clinician behaviors, usage trends, and Merck’s potential pricing plans could all help to offset any possible drops in sales. Gould also emphasized the new ambiguities surrounding the ACIP’s position, implying that these could make it more likely that the committee will approve a 1-2 dose regimen at the next June meeting.
HIV Protection With Just Two Shots a Year: FDA Approves Gilead Drug
The U.S. Food and Drug Administration approved Wednesday a powerful new drug that provides nearly complete protection against HIV infection with just a single administration every six months.
The injection, known chemically as lenacapavir and to be marketed as Yeztugo, has been hailed as the closest thing the field has ever had to a vaccine — a groundbreaking intervention that, if rolled out properly, could bring a 45-year-old pandemic to heel.
Drugs to prevent HIV, called PrEP, have been around for a decade, but they generally require taking a daily pill and have not substantially curbed global infections. “It really could be a game changer, particularly in areas heavily affected by HIV,” said John Brooks, former chief medical officer of the Center for Disease Control and Prevention’s division of HIV prevention.
