Tag Archives: FDA

FDA doublespeak: How the FDA promotes homophobia in the medical world

Since the legalization of same-sex marriage throughout the United States, many gay individuals and allies seem to believe that the government has granted full legal equality. Sadly, this is not truly the case, and the fine print of the recent overturn of a 30-year FDA blood ban from gay and bisexual men truly shows how our system continues to act against LGBT Americans.

The blood ban was not removed. The FDA merely changed it from a lifetime ban to a requirement that a potential donor abstain from sex with another male for an entire year. This might seem like an advancement for equality, but in reality it’s a mere reconstruction of a discriminatory policy promoting HIV stigma, and reinforcing the belief that AIDS is a “gay” disease.

The FDA blood ban was first enacted during the initial breakout of the disease as a measure to prevent spreading the virus, but since then the law has become outdated primarily due to new technology. According to the FDA, testing of donated blood has reduced HIV transmission through  donated blood from 1 in 2500 to 1 in 1.47 million. With such great progress HIV screening, the restrictions on men who have had sex with men is not only discriminatory but also highly unscientific.

Continue reading at The Hill.

Beyond Mylan: FDA Efficacy Requirements Hurt the Poor

Contrary to the popular belief that the U.S. Food and Drug Administration (FDA) protects American consumers from dangerous drugs produced by malicious drug companies, FDA drug regulations actually benefit big pharma. And this benefit occurs by increasing the cost of prescription drugs for the poorest Americans. We can see this injustice in the recent EpiPen controversy.

The drug company Mylan recently announced that they were increasing the price of their drug known as the EpiPen by nearly 500 percent since 2007. The EpiPen is a device that allows someone suffering from potentially fatal allergy symptoms to inject epinephrine into their system, reducing the symptoms and possibly saving their life. Since the drug is widely used and so important for many people, the price increase ignited a political and media firestorm. Pundits from both sides of the aisle are outraged, saying that the company should be forced to lower the price.

But the drug company is not the only organization at fault. Like any other corporation, Mylan is in business to make money. The FDA, on the other hand, whose official vision is that “public health is advanced and protected,” goes against this mission every day.

Continue reading at RealClearHealth.

How The New E-Cig Rules Hurt Americans

The FDA’s new regulations will destroy 99 percent of an industry that offers an option the Royal College of Physicians finds is 95 percent safer than cigarettes.

It is disheartening to see that the media’s near-exclusive focus while covering the Food and Drug Administration’s recent tobacco “deeming regs” has been on the provision that restricts e-cigarette sales to minors. The New York Times published an editorial entitled “Keeping E-Cigarettes Away From the Kids,” and the Huffington Post ran an article with the headline “Finally—Commonsense Protections for Our Kids From Tobacco.”

Most people agree minors should not have access to products that contain substantial levels of nicotine (and “substantial” is used because many foods contain trace amounts of nicotine). But, in focusing on this move, commentators are missing how the FDA’s new regulations will destroy 99 percent of an industry that offers an option the Royal College of Physicians finds is 95 percent safer than cigarettes.

The FDA’s regulations will force all e-cigarette products to go through the costly and time-consuming premarket tobacco product application process, a step that all but the big tobacco companies will not be able to comply with.

Read the full article at The Federalist.

FDA’s New E-Cig Regs Will Kill

The Food and Drug Administration released its long awaited e-cigarette regulations on Thursday. E-cigarette users’ worst fears are confirmed—these regulations will destroy the burgeoning industry, leading to increased mortality and higher healthcare costs.

Though the FDA marketed its regulations as restrictions on minors who purchase tobacco products, the 499-page release contains far more. Perhaps the most ridiculous FDA claim is that these regulations will lead to increased innovation—even though the agency admits that 99 percent of the market will not be able to comply.

As stated on page 267 of the regulations, “FDA believes that [premarket review] (and the deeming rule as a whole) will not stifle innovation but could, instead, encourage it.” This is a nonsensical claim that could only be made by a government agency.

Through these regulations, the FDA “deems” that all tobacco products are under its regulatory scope. Hookahs, cigars, pipe tobacco, and electronic nicotine delivery systems (ENDS) were not previously covered under the FDA’s authority to regulate tobacco, which began with the 2009 Family Smoking Prevention and Tobacco Control Act. Now, all tobacco products that were not commercially marketed on February 15, 2007 (the predicate date) are required to gain FDA approval. Tobacco products that were available on the predicate date are exempt from the FDA approval process.

Newer tobacco products will be able to stay on the market if they show that they are “substantially equivalent” to a product that was commercially available on predicated date. Virtually no ENDS were available to American consumers at that time, meaning each currently available vaping product will have to go through the FDA’s other path to market, the premarket tobacco product application process.

Read the full article at Economics21.

GM Salmon Is Just The Beginning

The FDA has finally verified the safety and environmental sustainability of AquaBounty Technologies Inc.’s genetically modified (GM) salmon, after a wait of nearly 20 years. This means that the company’s product, called AquAdvantage Salmon, could soon be available to consumers.

Even after the drawn-out FDA review process, many people remain opposed to what they term “Frankenfish” and are demanding legislative action to ban GM animal products or mandate labeling. These misguided efforts stand in the way of benefits to both consumers and the environment.

The enhanced variety of salmon can grow to the same market size as their wild counterparts twice as fast and with 75% less feed. This efficiency, driven by a growth gene that remains turned on, could lower AquaBounty’s carbon footprint 25 times over and result in lower costs for consumers.

Read the rest on Forbes here.