Accelerated approval is intended to get needed drugs to patients, but there are sometimes distortions and complications in the process that should be addressed.
FDA
Drug shortages mean that many patients are getting the second or third choice of a medicine, increasing the likelihood that the drug will be ineffective or only suboptimally effective, or have unwanted side effects. Reciprocity of approvals between the U.S. and certain other countries could help to address that.
Cutting the dose of Tylenol in opioids makes the drugs safer. Why? Pharma company Johnson & Johnson is developing a drug that could reduce liver damage caused by Tylenol — which J&J also sells.
The agency's primary functions are ensuring food safety, regulating tobacco products rationally, and expeditiously approving new drugs and medical devices. It's failing. Instead, we're getting increasingly complex organizational structures and the commissioning of endless reports.
Social justice advocates continue to demand that professions like medicine become more "diverse." Critics contend this development could bring unqualified physicians into the profession and jeopardize public health. Should we be worried? The FDA wants to label certain foods in the grocery store "healthy." It's an awful idea.
Whenever I think of Teddy Roosevelt, I imagine a hyper-talkative exuberant extrovert. He was known as an environmentalist, historian, and writer, but sadly his contributions to public health are obscured by his “larger than life” personality.
Panicked headlines recently warned that the popular artificial sweetener erythritol could increase heart disease risk. The study that generated these claims in no way supports that association. Dietary supplements are a multi-billion-dollar industry; they've also killed people. Do they need more regulatory oversight?
America is facing a critical shortage of many medically important drugs. The good news? There's a simple solution if we're willing to implement it. The Biden Administration is poised to invest billions of dollars in America's "bioeconomy." Will this really boost the US biotech sector, or just waste valuable resources that should be spent elsewhere?
Shortages of widely prescribed drugs are endemic in the U.S. To address the problem, we need a policy change that would enable overseas manufacturers to sell products in the U.S. that already have received marketing approval from certain foreign governments with standards comparable to ours and vice versa. In other words, there should be reciprocity of drug approvals.
The FDA actively – and unusually – collaborated with a biopharmaceutical company to pursue the approval of an Alzheimer's Disease drug, despite many questions about its efficacy and astronomical price. A congressional investigation found that the FDA’s approval process was “rife with irregularities" and that the agency’s actions “raise serious concerns about FDA’s lapses in protocol.”
"It can disappear in a moment," Dr. Chuck Dinerstein said after his near-fatal battle with a pulmonary embolism. How should our mortality influence our worldviews? Unregulated medical devices may put patients in harm's way. Why is the Cleveland Clinic parroting anti-vaping talking points from the Truth Initiative?
The FDA has tried to fight opioid addiction by asking patients to mail their excess prescription pain meds to the agency for disposal. It's an absurd proposal. There's lots of anti-pesticide 'facts' floating around the internet; let's debunk the most popular of these claims.