Researchers may now have to make clinical study results public— even if the results run counter to the interests of Big Pharma. Action Alert! In response to mounting concerns that important health data has been kept hidden from physicians and their patients, the National Institutes of Health (NIH) and the Department of Health and Human Services […]
If you thought the FDA was hostile only to supplements, think again. The agency is also unfriendly to drugs no longer under patent. Aspirin is a very old drug. It is no longer under patent protection, which means there is no longer any financial windfall to be made from it. We have reservations about taking […]
Even OTC sleep meds may be hazardous—and may contribute to Alzheimer’s. One of the world’s most popular sleeping pills is also, at 40 million prescriptions per year, one of the most-prescribed medications, period. Ambien—also sold under the brand names Intermezzo, Stilnox, Stilnoct, Sublinox, Hypnogen, Zonadin, Sanval, Zolsana, and Zolfresh—is becoming better known for its disturbing side […]
—and why their decision will have far-reaching ramifications for state licensing boards. Last year we told you about the Federal Trade Commission’s investigation of the North Carolina dental board. The FTC decided the board had attempted to monopolize the teeth whitening business, and found it had illegally thwarted competition through cease-and-desist letters. The board—composed mainly of private dentists—had […]
The FDA seems to be waiting for GMO soybeans to be ready before it follows through on its promise to ban the toxic fats. A new study published in the journal Preventing Chronic Disease, available on the CDC’s website, shows that Americans are consuming much more trans fat than they realize. A federal loophole allows food companies […]
Recent regulations released by the FDA contain several provisions that are harmful to doctors, patients, and compounding pharmacists. Office Use: This is an area of the rulemaking that has garnered the biggest reaction from the compounding community. Congress and the FDA have required a patient-specific prescription for all drugs compounded, with a narrow exception if […]
Compounding has recently undergone a regulatory overhaul by Congress and the FDA. In November 2013, the Drug Quality and Security Act (DQSA) was signed in to law, amending the federal Food, Drug, and Cosmetic Act (FDCA) and overhauling the regulation of compounding. In July 2014, the FDA released rules and guidances and other documents implementing […]
Patent protection means you get to charge whatever the market will bear. In this case, it bears a 935% increase in the price tag.
Why are these approaches being ignored? Could it be because there is little profit to be made from them? Action Alert!
