New FDA Supplemental Guidelines Has Booming Industry Upset

A new proposal to toughen the Food and Drug Administration’s power to regulate dietary supplements has the makers of vitamins, minerals and botanical extracts in an uproar.  They are mad and upset at the new guidelines and believe that they are too strong.  But other’s simply don’t agree.  One editorial found in the New England Journal of Medicine says the drug-safety agency’s proposed new powers are not nearly strong enough.

Each year, Americans spend more than $28 billion on supplements assuming that they are both safe and effective. More than 100 million Americans consume vitamins, minerals, herbal ingredients, amino acids, and other naturally occurring products in the form of dietary supplements. By law, dietary supplements with established ingredients — ingredients that were sold in the United States before 1994 — may be marketed without any evidence of efficacy or safety.

But to expand its current $28-billion-a-year market, the dietary supplements industry is widely devising and selling formulations that use “novel” products — minerals, plants, or amino acids that appear newly promising, which have not circulated widely in the United States before, or which are offered in “mega-doses” much higher than have been customarily used in supplements.

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Deaths Reported After Doctors Ignored Kenalog Warning & FDA Failed To Adequately Warn

Seven months ago Bristol-Myers Squibb issued a public safety alert and changed the label of the Kenalog injection to indicate that use of it in epidurals had been linked with “serious medical events, including death” and that use of it as an epidural injection was “not recommended.”

But according to reports Doctors are still injecting the steroid in a way the company warns they shouldn’t, following reports that patients have died or become paralyzed after receiving steroidal shots.

The company will not go so far as to say Kenalog was responsible for those deaths or injuries and the Food and Drug Administration failed to issue its own alert, as it usually does, when Bristol-Myers Squibb changed the labels on Kenalog.

Used for neck and back pain, Kenalog and the Pfizer Inc. (PFE) drug Depo-Medrol are the most frequently administered steroids in epidural injections. Over eight million such shots were given in the U.S. in 2010.

Bloomberg reports that experts believe this warning from the drug company has largely gone ignored or unnoticed.

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FDA Finally Addresses Social Networking Issue & Gives Guidelines On How To Interact With Consumers

The FDA is issuing new rules to pharmaceutical companies regarding how they are to interact with consumers on social media. The rules will not yet have an impact though as companies say they need more clarification from the FDA before they’re comfortable getting back online again, according to The American Medical Association (AMA).

The agency’s draft guidance says all unsolicited information requests be handled in a nonpublic format. The AMA noted that requests include doctor requests for details on the off-label uses of certain medications.

One of the rules encourages all responses to unsolicited requests for information be made in a nonpublic format. That includes requests from physicians for information on off-label uses for certain drugs.

The FDA is also requesting that companies respond to public requests sent Facebook or Twitter, by guided to the appropriate personnel or department for private, one-on-one help. Private responses should be science-based and answer only the question asked, said the AMA.

The new guidance does not affect information or requests received in answer to industry solicitation and do not affect social media sites maintained by physicians or health care organizations, said the AMA. The AMA and some other physician organizations have issued their own guidance to members that includes advising members to proceed cautiously and maintain patient privacy laws when communicating online with patients, said the AMA.

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Novartis To Pay A Whopping $99 Million In Class Action Lawsuit

Novartis is getting ready to shell out a lot of dough!  In a recent lawsuit brought by sales representatives who claimed they were denied overtime pay, the plaintiffs won a judge’s preliminary approval of a $99 million settlement.

The class-action settlement, tentatively approved on Tuesday, January 24, 2012, by U.S. District Judge Paul Crotty in Manhattan, covers more than 7,000 current and former sales representatives, according to a statement by the company and lawyers for the workers.

“We believe this settlement is in the best interest of our employees and the company,” Andre Wyss, president of Novartis Pharmaceuticals Corp., said in the statement. “We have been litigating this case for nearly six years and the company has determined that it is time to resolve these wage and hours claims.”

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Johnson & Johnson Suffering From Manufacturing Issues and Recalls

The drug & medical device giant Johnson & Johnson seems to be a name that is coming up a lot lately; from the controversial chemicals found in baby products to the major artificial hip recall surrounding DuPuy Orthopaedic’s, they continually seem to be on the radar.

Now, in their just released last quarter financial statement released, apparently all of this controversy is having some effect on the company’s bottom line and reveals deep holes in its profits.

According to the company’s most recent earnings statement, while Johnson & Johnson’s earnings were up, revenues were down sharply in the fourth quarter of 2011, in part because of product recalls and litigation, include the issues surrounding its DePuy unit’s defective ASR hip implant.

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