Category:

The Federal Trade Commission just cracked down on an unusual product that has long enjoyed exemption from regulation: homeopathic drugs. Available everywhere...homeopathic products are advertised as an effective way to treat a wide range of conditions...Americans spend over $3 billion a year on homeopathy, and the market appears to be growing steadily...companies selling these products have never been required to show they are effective at doing what they claim...the FTC announced its “enforcement policy statement” about homeopathic product labeling...the recommendations are pretty minimal...the agency produced a report that concluded customers were likely to be deceived by labels that did not carry the appropriate disclaimers, and therefore disclaimers stating that these products are untested will now be required. The requirement is not technically a law like…The rules require packaging to effectively communicate two key disclaimers:

•     “There is no scientific evidence that the product works.”
•     “The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”

The holidays came early for the pharmaceutical industry this year...With Donald Trump elected to the White House and Republicans controlling Congress, the companies that make your medicines can expect a friendlier environment in which to operate. And investors quickly responded by boosting drug and biotech stocks…So what lies ahead? Here are a few predictions:

• FDA will stand for Faster Drug Approvals - Many Republicans would like to speed the Food and Drug Administration process for getting new medicines to patients.
• Drug makers will have more leeway on pricing - A big bet now is that the Trump administration will not be as aggressive in tackling prescription drug prices as a Clinton administration might have been.
• Friendly tax policies are on the way - Another key piece of the Trump plan is tax reform. Again, the Trump team is short on details, but one plan floating around is to allow companies to repatriate money parked overseas and pay taxes of only 10 percent or less, instead of 35 percent.

It’s back to the drawing board for the FDA...After years of slow reaction to pharma marketing online, the agency announced this week a new research initiative to better understand how consumers process short-form posts and ads...the FDA is trying to determine whether links in tweets and Google ads can independently convey all the necessary information about product risk...Under current guidelines, drug companies are required to balance the information they provide in character-space-limited posts. That means for a typical 140-character tweet, at least 70 characters must be dedicated to explaining risks and side effects...Regulatory change could be good news for pharma marketers, who have for a long time sought clarity on what they can and cannot do...

A long-running debate in Nevada’s medical community is heating up, with doctors challenging a new regulation that would enable dental hygienists to administer Botox to patients for either medical or cosmetic reasons...The State Board of Dental Examiners...last month approved rules that would extend the privilege to licensed dental hygienists...But the Nevada State Medical Association, which represents the state’s practicing physicians, is pushing back. It says use of the toxin should not be extended to dental hygienists, who can be licensed after as little as two years of study at an accredited college, and that dentists should be restricted to applying it to certain areas of the head...Dentists...have called the dispute a "turf war," arguing that physicians are attempting to protect a lucrative and increasingly common medical procedure.

Teva has halted production at the Rimsa plant in Mexico and idled some of the workers, laying the blame for the issues at the feet of the brothers with whom they are battling in court over the $2.3 billion buyout...Teva acknowledged today that Mexican authorities suspended manufacturing at the plant in October saying the action followed...discovery of the serious violations committed under the Espinosa brothers, Rimsa's former owners....We are working closely with the Mexican authorities in order to restore production and products to the market…Mexico’s Federal Commission for Protection against Health Risks...took its action in response to a complaint by Teva. The agency is now said to be verifying that the 140 products manufactured at the plant in Guadalajara meet quality, safety and efficacy standards. COFEPRIS expects to complete its analysis by year-end...

Emily Lindley’s stash of marijuana is going to be very, very secure...Lindley, a neurobiologist, is about to begin the first study ever to directly compare cannabis with an opioid painkiller for treating people with chronic pain. She got a grant for this research two years ago, but it has taken that much time to meet all the requirements for working with a drug the federal government still considers highly dangerous...The current status of medical marijuana research is rife with irony. As states have liberalized marijuana laws, they’ve created new opportunities: Lindley’s grant is part of $9 million Colorado awarded for medical research in 2014, using tax money from marijuana sales. But since pot remains illegal at the federal level, researchers have to jump through regulatory hoops—lots of them—to do legitimate research...Physicians have commented for more than a century on the potential for cannabis to substitute for opioid drugs, and several recent studies seem to bolster this hypothesis...The idea has not been tested with rigorous clinical trials, however. Such trials are expensive, and they’re normally paid for by a pharmaceutical company hoping to bring a new drug to market. Because a plant that exists and reproduces in nature can’t be patented, cannabis offers few opportunities for patents (and thus profits), which makes it look like a loser to most companies...Lindley is eager to get on with her study...Given that so many people are already self-treating with marijuana, Lindley says, it’s important to know whether there are actually therapeutic effects. “I’m not a proponent one way or another,” she says. “I think we need to do the research.”

Nevada Gov. Brian Sandoval told the state dental board to address problems with its patient-complaint-resolution process at a heated meeting...in which dental professionals accused the regulators of corruption, bullying and extortion...“There’s something not right here and it needs to be fixed,” the Republican governor said after hearing complaints and tearful accounts about the alleged problems...The current process...left dentists and other practitioners believing they either had to accept a settlement agreement or risk steeper punishment if found at fault during a final board hearing...Either pay me now or we’ll look into it deeper and you’ll pay me more...

Teva is trying to clean the slate on its history of allegedly paying bribes in foreign countries to boost sales. Having revamped its governance programs and set a new tone about bad behavior, it has now put aside more than half a million dollars to cover anticipated settlements with U.S. authorities...Teva revealed it was in “advanced discussions” to settle investigations by the Justice Department and SEC into violations of the Foreign Corrupt Practices Act and set aside about $520 million to cover the expected settlements. It said those discussions concern matters that occurred in 2007-2013 in Russia, Mexico and Ukraine...Teva emphasized that none of the conduct involved its U.S. business, inferring instead that it was problems with third parties and subsidiaries. It pledged to do whatever it can to prevent a repeat...The compliance program that Teva has in place now is serious, rigorous, and comprehensive and is designed to protect the company and its subsidiaries against future violations…

Seeking to address rising concerns about prescription medicines, the watchdog arm of the Department of Health Human Services is adding to its list of pharmaceutical issues to be examined...The...Office of Inspector General...is trying to widen its focus as questions accelerate about drug costs and the sources for some medicines, according to a new work plan released today...the new issues that are being studied: the amount of medicine that may be wasted when cancer treatments...are distributed in single vials; the amount of money the government might save in the Medicare Part B program if rebates were tied to inflation; and questionable billing for topical medicines that are compounded and covered by Medicare Part D...The OIG is devoting more resources and “drilling down” as concerns rise over drug pricing and accompanying billing patterns...Prescription drug oversight is a top priority…

A prominent organization of defense lawyers in Las Vegas this week formed a committee to explore ways of challenging local law enforcement’s methods for gaining drug convictions...The committee, set up by the Nevada Attorneys for Criminal Justice, will look at the use of what are known as chemical field tests, inexpensive kits used by police and prosecutors to make drug arrests and gain guilty pleas. Officers typically drop suspicious materials into a chemical pouch and look for telltale shifts in color ostensibly meant to indicate the possible presence of illegal drugs. The tests are often the only evidence used to win convictions...The Las Vegas Metropolitan Police Department crime lab had submitted a formal report detailing the shortcomings of the tests to federal authorities in 2014, and yet to this day the lab still endorses the use of the tests in criminal prosecutions...