Tag Archives: FDA

FDA Finally Certifies Pfizer COVID-19 Vaccine as Fully Approved

Despite the fact that hundreds of millions of Pfizer-manufactured mRNA vaccines have been injected into people’s arms, until today the shot’s widespread consumption has been only under an “Emergency Use Authorization.” Today the US Food and Drug Administration has decided it can throw its full weight of approval behind the vaccine, opening the way for organizations, governments, and other large entities to mandate vaccination for staff and others.

It is expected that the certification, which has been in process since the vaccine entered the world stage in December 2020, will increase confidence in the treatment, helping overcome the last traces of vaccine hesitation which has led in part to the current surge in COVID-19 around the world, due to the spread of the Delta variant.

The US defense establishment announced that it will in all likelihood make vaccination mandatory for all members of the armed services. Universities have also said that they will require students and staff to be vaccinated if they want to attend in-person learning, among them the University of Minnesota and major public universities in Louisiana.

The FDA said it was able to upgrade the approval rating based on the large amount of hard evidence proving that serious side-effects are highly unusual, and the benefit of the vaccine vastly outweigh any risk presented by its administration.

President Joe Biden said, addressing those who have been wary of the vaccine because it was only being given under the emergency use authorization, that now that the vaccine has received the “gold standard” approval, “the moment you’ve been waiting for is here!”

Wrong Dosage Forces FDA Recall of Generic Lipitor

Lipitor Recall
Lipitor Recall

In what is at least the third recall of generic Lipitor in the past two years, The Federal Food and Drug Administration announced a Class II recall of the Ranbaxy Laboratories Ltd product.

Over 64,000 bottles of the medication that lowers cholesterol levels were recalled in the United States as a reaction to the discovery by a pharmacist of a 20-milligram tablet in a sealed bottle which was marked as containing just 10-milligram tablets.

A Class II recall means that there is only a slight chance that severe bad consequences or death will ensue due to the problem. Ranbaxy, located in India, did not comment on the recall announcement.

Ranbaxy is India’s largest drug manufacturer by revenue. In November 2012 the company recalled 480,000 bottles of atorvastatin calcium, the generic name for Lipitor’s active ingredient, due to the discovery of tiny particles of glass by the company.

New Sunscreen Labels Help Consumers Get Better Protection

Sunscreen Labels are More User Friendly Thanks to New FDA Regulations
Sunscreen Labels are More User Friendly Thanks to New FDA Regulations

The consumer protection watchdog organization Environmental Working Group is by and large satisfied that most sunscreen products do meet new federal labeling standards which were put in place last December.

The new rules established by the Food and Drug Administration require that sunscreens filter out both UVA and UVB rays. Previously many of the sunscreen products only filtered the sun-burning UVB rays, while not providing sufficient protection against the cancer and wrinkle-causing UVA rays.

Sunscreens must refrain from claiming that their products are “waterproof,” which FDA officials say is misleading. Not dealt with, however, by the new rules, is the misleading labeling of sun protection factors (SPF) above 50, which for a long time now have been seen by experts a problematic use of a numerical system to rate sunscreen products.

“The high SPF numbers are just a gimmick,” says Marianne Berwick, professor of epidemiology at the University of New Mexico. “Most people really don’t need more than an SPF 30 and they should reapply it every couple of hours.”

Berwick says sunscreen should be used in combination with hats, clothing and shade, which provide better protection against ultraviolet radiation.

“The challenge is that beyond 50 the increase in UV protection is relatively small,” says Dr. Henry Lim, chair of dermatology at the Henry Ford Hospital in Detroit.

In 2011 the FDA itself stated: “Labeling a product with a specific SPF value higher than 50 would be misleading to the consumer.” That year the FDA suggested a limit on SPF values at 50 since “there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users.”

Companies that produce sunscreens, such as Johnson & Johnson say that there are measurable benefits provided by sunscreen products with higher ratings than 50. Due to the objections of the sunscreen product manufacturers the FDA is continuing to review the studies and other opinions about placing a cap on SPF ratings.

‘Hey Good Looking’: Good Marketing Technique

Weight Loss Surgery Adverts

It’s genius when you think about it. Everyone wants to look good so why not use that as a marketing technique to promote bariatric surgery? The postcard used in the ad has the faded denim look, subconsciously reminding someone desperately trying to lose weight about the dream-jeans they want to fit into. TriStar Health Systems and Baptist Hospital is “aggressively marketing the weight-loss surgery” in this way. Over 60 percent of America’s female adult population is overweight; for this proportion, surgery may be the answer.

US Admin Pushes Surgery

Even official bodies are now – at least indirectly – pushing this surgery. The US Food and Drug Administration has reduced the acceptable weight for the “most popular and least invasive procedure.” Hospitals however, are looking for patients who want to pay since insurance companies have still not “embraced this lower threshold.”

Pretty Marketing Techniques

It’s been done a million times, but it keeps reaping success; pushing pretty people in marketing techniques. This is exactly what is working for the weight-loss surgery too (not surprisingly). But on the flip side, the reality could be different since there are potential complications and risks from undergoing such surgery (as with any surgery) and it is not “an automatic cure for obesity.” The marketers are claiming something different though, saying that they are just pushing this as “an awareness piece,” since many individuals just don’t know about the bariatric surgery and various other available options. So while it is a great marketing technique since such a substantial proportion of the American population is overweight and even officially obese, looking at pictures of pretty, thin people should not be the determining factor in deciding whether this surgery is right for you. Each individual case needs to be assessed on its own merits.