Archive for the ‘Regulatory’ Category

FDA Approves first flu vaccine using mammal cell cultures

Wednesday, November 21st, 2012

On Tuesday, the FDA announced that it approved the first flu vaccine comprising animal cell cultures.   The vaccine, to be marketed under the trademark FLUCELVAX, is a Novartis product.  FLUCELVAX will be manufactured in Novartis’ brand new North Carolina plant.

The vaccine is produced with virus strains that are grown in animal cell cultures derived from mammals instead of in chicken eggs. Similar cell culture technology has long been used to produce other types of vaccines, FDA said.

FDA press release here.

Posted in Pharmaceuticals, Regulatory, Trademarks | No Comments »

FDA Approves New Sunscreen Rules, Finally

Tuesday, June 14th, 2011

After 30 years in bureaucratic limbo, the FDA has approved new rules, published today, intended to alleviate consumer confusion about sunscreen effectiveness.

In order to claim they protect against skin cancer, sunscreen manufacturers will have to prove they filter out bothultraviolet B rays and ultraviolet A rays.  Additionally, any sunscreen with an SPF of 15 or less will have to bear the following warning:  ”This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

The key takeaway for consumers: Look for a sun protection factor, or SPF, of 15 and above that also says “broad spectrum.” That’s the new buzzword from the Food and Drug Administration to describe a product that does an acceptable job blocking both types of damaging rays.

The new regulations require that sunscreens be tested for the ability to block the more dangerous ultraviolet A rays, which can penetrate glass and pose the greatest risk of skin cancer and premature aging. Currently, the FDA requires testing for only ultraviolet B rays that cause sunburn. The current SPF labeling system only deals with ultraviolet B rays.

Under the new rules:

• The FDA will prohibit sunscreen marketing claims like “waterproof” and “sweatproof,” which the agency said “are exaggerations of performance.”

• The FDA also proposes capping the highest SPF value at 50, unless companies can provide results of further testing that support a higher number.

• FDA says manufacturers must phase out a four-star system currently used by some companies to rate UVA protection.

After reviewing more than 3,000 public comments, the agency concluded the star system was too confusing for consumers. Instead, protection against UVA should be proportional to protection against UVB, which is already measured using SPF.

Posted in Government Action, Pharmaceuticals, Regulatory | No Comments »

P&G Gets Warning Letter

Wednesday, September 19th, 2007

Yesterday, the FDA ordered Procter & Gamble to stop advertising that its Vicks foaming sanitizer for hands (product here) prevents the spread of viruses (that cause colds.

The FDA is reviewing health claims for over-the-counter antiseptics made by P& G, Johnson & Johnson and other companies. While the active ingredient in the Vicks product, triclosan, is covered under FDA. regulations for certain antiseptic uses, that does not include P& G’s directions that users should leave the sanitizer on their hands, without rinsing with water, according to the letter.

“We believe we’re within the FDA guidelines, and we’re going to work with the FDA to clear up any misunderstandings,” said David Bernens, a spokesman for P&G.

Posted in Business of TMs, Government Action, Pharmaceuticals, Regulatory | No Comments »

Pfizer Takes Unusual Position

Friday, January 26th, 2007

A top lawyer at Pfizer last week took the unusual position of publicly endorsing the right of drug companies to practice off-label marketing in certain instances.

Arnold Friede, senior counsel at Pfizer, said pharma firms should be able to distribute information on unapproved drug uses if the information is “truthful and not misleading,” and published in a medical journal.

It is an interesting read.  The article emphasizes the notion that few companies challenge the FDA for fear about FDA reprisal when it comes to the approval of new drugs:

Drug companies fear challenging the FDA when they disagree with its guidance on drug promotion, Friede said, because “given the fact [the FDA also has] control over most drug approvals, most companies will not fight to the death.”

The perception in the industry is that the FDA “might exercise that lever” with a drug company that opposed it over the off-label issue, Friede said.

This is interesting as it is one of the first public endorsements of this proposition by a pharmaceutical company.

It seems to me that the pharmaceutical industry – as a whole – could find a way to challenge the FDA’s purported First Amendment violations while avoiding reprisals against individual pharmaceutical companies.

Posted in Branding, Business of TMs, Pharmaceuticals, Politics, Regulatory, Trademarks | No Comments »