—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 […]
Compounding is a method of preparing medications that are individualized for a patient’s specific needs. Compounding is when a licensed pharmacist, a licensed physician, or a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Compounding […]
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 […]
Last week saw an inter-agency power grab. It begins with the weakening of organic standards—and could end with the term “organic” becoming practically meaningless. Action Alert! In September, the USDA announced changes to its interpretation of the “sunset” provision in the Organic Foods Production Act (OFPA), an incredibly important piece of legislation that Congress passed […]
Patent protection means you get to charge whatever the market will bear. In this case, it bears a 935% increase in the price tag. Xyrem is the brand name for sodium oxybate. Sodium oxybate is the sodium salt of γ-hydroxybutyric acid, or GHB—the “date rape drug.” It’s an old drug—even older than aspirin—and it’s FDA-approved […]
…and turn supplements into drugs. What is this agency thinking? Action Alert! What the FDA does about supplements is usually complicated—we think intentionally so, in order to confuse Congress and critics. Bear with us as we try to disentangle the threads. We need to get this story out now because the FDA has just opened a […]
And if scientific research about them is published, the FDA will take them away—forever. Action Alert!
Patent protection means you get to charge whatever the market will bear. In this case, it bears a 935% increase in the price tag.