Are You Marketing a New Drug? FDA Will Do Its Best to See That You Have No Competition from Any Source!

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… Continue reading Are You Marketing a New Drug? FDA Will Do Its Best to See That You Have No Competition from Any Source!

How a Tooth-Whitening Lawsuit Landed before the Supreme Court

—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… Continue reading How a Tooth-Whitening Lawsuit Landed before the Supreme Court

Problems with Compounding Regulation?

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… Continue reading Problems with Compounding Regulation?

How is Compounding Regulated?

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… Continue reading How is Compounding Regulated?

FDA Approves Controversial Diet Drug Despite Warning of Suicide Risk

Contrave has terrible side effects, is expensive, includes a hidden antidepressant, and barely even works. So why did the FDA approve it? Action Alert! The FDA approved two weight loss drugs in 2012, Qsymia and Belviq, but sales have been sluggish. This week FDA approved Contrave, even though the FDA initially denied approval to Contrave in… Continue reading FDA Approves Controversial Diet Drug Despite Warning of Suicide Risk

Congressional Committee Says FDA Is Overstepping Its Jurisdiction

A powerful subcommittee says a new FDA proposal on medical testing will stifle innovation and may not be legal. Action Alert! Three months ago we told you about laboratory-developed tests (LDTs)—inexpensive diagnostic tests for patients that are developed and performed by local labs. They include standard tests but also new ones, genetic tests, tests for… Continue reading Congressional Committee Says FDA Is Overstepping Its Jurisdiction

Which Supplement Companies Do the Experts Swear By?

First we asked our trusted natural health doctors and integrative physicians about supplement brands they recommend. We then added to the list based on our staff and board experience. Please note that our list is not exhaustive; there are many excellent companies who pay a great deal of attention to quality and efficacy, and not… Continue reading Which Supplement Companies Do the Experts Swear By?