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Health

The Obama Administration’s New Plan B Policy Is Still Catering To Big Pharma

Teva Pharmaceuticals

After a long and contentious legal battle, the Obama administration announced Monday it would allow women of all ages to buy Plan B One Step, the most popular emergency contraception pill, without a prescription. Women’s health advocates celebrated the decision, which reverses the administration’s scientifically unjustified restrictions on the so-called morning-after pill for women under 17.

But even after removing age restrictions, women may still face steep costs for the pill if the administration ignores the court order that required it to open access to all emergency contraception pills, not just the Plan B One Step brand. If the FDA decides to clear only brand-name Plan B but keep the cheaper generic versions behind the counter, the morning-after pill may become even more expensive than it already is.

U.S. District Judge Edward Korman ordered the FDA to approve all levonogestrel-based emergency contraceptives for over the counter use in April. Instead, the Obama administration chose to lower the age restriction on Plan B One Step from 17 to 15-years-old. This effectively made Plan B One Step the only morning-after pill available over the counter for 15 to 17-year-old girls. Korman attacked the move as a “sweetheart arrangement” with Teva Pharmaceuticals, the manufacturer of Plan B.

The judge observed that the Obama administration’s arbitrary compromise would benefit Teva immensely: “A consumer looking for an emergency contraceptive would only find Plan B One-Step on the shelves, and if she came in after the pharmacy counter was closed, her only option would be Plan B One-Step.”

Under this agreement, the price of the pill could reach $60 or even higher. Generic versions, which may not be approved for over the counter use, tend to be much more affordable for young women, at about $30 to $40.

Teva Pharmaceuticals is well aware of this special treatment. The company even tried to intervene in the lawsuit, arguing that Plan B One Step should have marketing exclusivity over generic emergency contraceptives. Korman flatly rejected this claim.

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Health

Why The FDA Takes So Long To Regulate Harmful Substances

(Credit: Next Generation Food)

On Thursday, Wrigley announced that it would be pulling its controversial new “Alert Energy” gum — each stick of which contains as much caffeine as half a cup of coffee — from the market out of “respect” for the U.S. Food and Drug Administration (FDA) as the agency investigates the public health risks associated with pumping caffeine into everyday foods and drink. With energy products and other potentially harmful foods high in sugar, salt, and fat increasingly under public scrutiny, it’s worth asking: why can’t the FDA do more to crack down on these additives? And why does it take so long to get food makers to comply with regulations when they do?

Answering that requires a brief foray into the history of the American food safety regimen. 1958 was a seminal year for food oversight, seeing the passage of the Food Additives Amendment to the Food, Drug, and Cosmetic Act, and the creation of the Generally Recognized As Safe (GRAS) List. Under the Food Additives Amendment, “any substance intentionally added to food is a food additive and is subject to pre-market approval by FDA unless the use of the substance is generally recognized as safe (GRAS).” So if a substance is on the GRAS exemption list, then food makers can use it to their heart’s content without proving its safety, unless specifically prevented from doing so by an FDA regulation.

The GRAS list contains over 700 items, many which have been there since 1958 — and taking an item off the GRAS list once it’s on is difficult. GRAS items are specifically defined as substances that are “generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of [their] intended use.” Consequently, revoking a substance’s GRAS designation requires considerable expert consensus that an item is not safe for its intended use.

One might ask how salts, sugars, trans fats, and caffeine don’t fit that bill considering widespread evidence that those substances increase the risk of heart disease, stroke, obesity, hypertension, and diabetes, thereby harming public wellness and increasing U.S. health care costs. In fact, government watchdogs and medical groups such as the Government Accountability Office (GAO) and the American Medical Association (AMA) have issued several calls for the FDA to crack down on those very ingredients.

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Health

Wrigley Pulls Its Caffeinated Gum Off The Market After Mounting Pressure From The FDA

(Credit: Flickr)

Earlier this month, Wrigley became the latest company to launch a line of caffeinated gum with its new “Alert Energy” product, which contains about half as much caffeine as a cup of coffee in each stick. But now, in the wake of the Food and Drug Administration’s concern about the product’s potential effect on children, the company is pulling Alert Energy from the shelves.

The FDA recently met with Wrigley to express its concerns over the new gum’s safety for children. Although there are other types of caffeinated gum on the market, they’re all sold by companies that solely specialize in energy products — so, even though Wrigley promised it wouldn’t be targeting its new gum toward kids, the FDA worried it might not be as clear to parents and children that Alert Energy does contain an additive. The federal agency, concerned about the growing trend of marketing caffeinated products to children, announced that it will launch an investigation into the effects that added caffeine has on children.

While FDA officials have acknowledged that enforcing an age restriction for caffeine is unlikely, they point out that carding Americans for coffee is an entirely different issue than regulating the amount of caffeine that may be added to products that kids typically enjoy. “For me, the more fundamental questions are whether it is appropriate to use foods that may be inherently attractive and accessible to children as the vehicles to deliver the stimulant caffeine,” Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, explained.

Talyor applauded Wrigley’s decision to stop producing and marketing its Alert Energy gum. “The company’s action demonstrates real leadership and commitment to the public health,” he said, noting that the FDA’s role in regulating caffeinated products remains unresolved while the agency pursues its current investigation. “We hope others in the food industry will exercise similar restraint.”

Energy drinks are another highly-caffeinated product receiving increased scrutiny in recent months. After emergency room visits related to energy drinks more than doubled over the past five years, health advocates started calling on the FDA to strengthen its regulatory oversight over this sector of the beverage industry — which often gets around FDA guidelines by classifying energy drinks as “dietary supplements” rather than “drinks.”

Health

Judge Mocks Obama Administration’s Attempt To Restrict Morning After Pill As ‘A Charade’

U.S. District Judge Edward Korman did not take well to the Obama administration’s appeal of the judge’s recent order to lift all age restrictions on the Plan B “morning-after pill.” In his original ruling last month, Korman chided the administration for its “political interference” into the FDA’s recommendation to allow women of all ages to obtain emergency contraception without a prescription. On Tuesday, the federal judge did not hesitate to express his displeasure once again, calling the Justice Department’s appeal “a charade.”

During a hearing in Brooklyn, Korman accused the administration of trying to “sugarcoat this appeal of yours” to hide their true attempt to stall the court order. Though the court’s ruling is not expected until the end of the week, Korman made his outrage over the “total and complete corruption of the administrative process” quite clear:

When the government lawyer argued that delaying Korman’s order while it was on appeal was in the public interest, the judge responded, “Is there a public interest in unwanted pregnancies … that can often result in abortions?”

The judge also expressed outrage at another provision under the new FDA rules that would require government-issued photo identification to get the pills, placing an “impossible burden” on disadvantaged people without IDs.

“The poor, the young and African-Americans are going to be put in the position of not having access to this drug,” he said.

Making the same point earlier, he asked, “Is that the policy of the Obama administration?”

Korman also speculated that the FDA’s new policy restricting Plan B for girls under 15 instead of under 17 was intended to undermine his ruling, which would have removed all limits on the drug’s availability this week. Indeed, the Obama administration’s apparently arbitrary age limits have no basis in scientific research. Multiple studies have found Plan B to be safer than even aspirin for all ages. Moreover, making women prove their age before buying Plan B creates an unnecessary burden for undocumented women and teens who don’t have government-issued documents. Women’s advocacy organizations erupted in protest over Obama’s decision to appeal the court order to remove these limits.

Health

San Francisco Sues Monster Energy Drink Maker For Marketing To Kids

(Credit: CBS News)

San Francisco’s public attorney has filed a lawsuit against Monster Beverage, the maker of the popular Monster energy drinks, over concerns that the company is targeting its potentially-dangerous products to children as young as six years old in its advertising campaigns. Energy products like Monster have been coming under increasing scrutiny recently as reports of their adverse health consequences have been on the rise.

The lawsuit is the latest skirmish in a battle that began when the parents of a 14-year-old girl with pre-existing heart conditions — who died after consuming several cans of the product in a 24-hour period — sued the company towards the end of last year. That prompted San Francisco city attorney Dennis Herrera to open negotiations with the drink maker in an effort to persuade them to use safer ingredients. Herrera claims that the talks were occurring in “good faith” — until Monster suddenly sued him last week over his product change demands, which Monster argues that only the Food and Drug Administration (FDA) has the authority to make. Now, Herrera is suing the manufacturer under the auspices of a California marketing and public health law, noting that Monster’s website “uses children as young as six years old to promote its brand.”

There have been at least five deaths and one heart attack potentially linked to Monster products since 2004. In fact, as energy products have grown in popularity, the number of energy drink-related emergency room visits ballooned to a staggering 20,000 between 2007 and 2011 — a two-fold increase in just four years. That’s led congressional leaders and FDA officials to focus attention on an industry that has, until now, largely been spared scrutiny over public safety concerns. Monster recently responded to this pressure by relabeling its products as “drinks” rather than “dietary supplements,” a move that frees it from its responsibility to report incidences of its products’ adverse public health requirements.

However, that same decision may end opening up Monster to more robust federal oversight. “Food” products must contain ingredients that are “generally recognized as safe” — something that critics argue do not fit the description of little-known caffeine-like substances used in Monster drinks such as taurine. The FDA recently announced that it would ramp up investigations into energy-enhanced food and drink products in the wake of health risk concerns and the emergence new concoctions such as Wrigley’s new “Alert” energy gum — each stick of which has as much caffeine as half a cup of coffee.

Justice

Big Agribusiness Is Tricking You Into Buying Cruelly Raised Eggs

Credit: Advocate for Saving Animals.

Everyone has seen labels on the eggs they buy in grocery stores like “organic” or “free-range.” What most people don’t know is that these loosely defined labels are often fig leaves that cover for the brutal abuse of animals.

But a new lawsuit by animal advocates may have changed all that, pressuring the Food and Drug Administration (FDA) on Monday into creating new labeling standards that require egg producers to be honest about what they do to egg-laying chickens.

Egg production is an almost entirely unregulated industry under federal law; a series of special provisions in major animal welfare legislation allows the egg industry to raise egg hens however they please. For example, the Humane Slaughter Act — the principal federal animal welfare law for farm animals — explicitly exempts poultry from the bill’s protections.

The result is an impossibly cruel farm system, where 95 percent of American chickens are raised in tiny, crammed cages that slice their feet, atrophy their muscles and slowly drive them insane. 25 states allow the poultry industry to define “customary” animal welfare practices however it likes to escape animal cruelty laws. One visitor to an egg “farm” saw mummified dead birds crowded in with live birds in tiny cages, thirsty and filthy birds, among other horrors.” A few plants even force their hens to undergo what’s called “forced molting,” depicted in the image above, where hens are starved until they lose their feathers in order to marginally improve egg production and quality.

Unsurprisingly, the vast majority of Americans don’t want to spend their money subsidizing a system that confines hens so cruelly. As a consequence, a complex labeling system has emerged to inform consumers about the humaneness of their various different egg options. Some of the labels, like “Animal Welfare Approved,” are stringent, third-party standards. Others, like “American Humane Certified” and “United Egg Producers Certified,” allow for precisely the sort of brutal caging these labels are ostensibly supposed to guide consumers away from. You can read a guide to the egg guides here.

The new lawsuit, filed by the Animal Legal Defense Fund (ALDF) and Compassion over Killing (CoK), may render such guides superfluous. The complaint argues that the FDA, by not forcing the industry to describe how eggs are produced in precise terms, is allowing the industry to willfully obscure the way it treats egg hens. As ALDF and CoK put it:

In spite of Congressional mandates, [federal] agencies have failed to take any action to regulate the often-misleading claims and deceptive imagery widely found on egg cartons. Even the United Egg Producers, the U.S. egg industry’s trade association, has endorsed federal legislation containing a similar labeling program.

Under the lawsuit’s petitioned action, egg producers nationwide would be required to clearly label egg cartons with egg production methods, including the identification of “Eggs from Caged Hens.” Co-plaintiffs in the lawsuit include several Bay Area egg consumers who have relied on deceptive egg carton labeling in their efforts to purchase eggs from hens not confined in cages.

On Monday, the FDA caved to the legal pressure. ALDF and CoK have stayed the lawsuit in response to the FDA’s decision to formally respond to a “federal rulemaking petition” on egg labeling by September of this year. Rulemaking petitions are requests from the general public and/or interest groups for a federal agency to change its administrative rules on a particular topic; there’s been an outstanding petition on egg labeling since 2006. The FDA is within its rights to deny the petition, so clearer egg labeling is by no means a given at this point.

Animal cruelty of all sorts is endemic to the American factory farming system. The cruel conditions double as “perfect breeders” for foodborne illnesses.

Health

FDA Pushes For Cancer Warning Labels On Tanning Beds In Effort To Fight Melanoma

(Credit: University of California, San Francisco)

The U.S. Food and Drug Administration (FDA) on Monday took steps to ensure that consumers are aware of the cancer-related risks of using commercial tanning booths. In its proposed rule, the FDA wants the booths “to carry language warning people under the age of 18 about the risks of indoor tanning” and “require manufacturers to meet certain safety and performance requirements before marketing their devices.”

If given final approval, tanning booths would also reclassify the machines themselves to “moderate-risk” products, and give the FDA more power to change their design to make them safer for public use:

Medical groups like the American Academy of Dermatology have been urging the U.S. government to take action on tanning beds for years, citing increases in the number of cases of skin cancer among women in their teens and twenties. Dermatologists say indoor tanning advertisements directly appeal to teenagers’ desire to be attractive.

Currently the machines are classified as low-risk devices, in the same group as bandages and tongue depressors. By increasing their classification to moderate-risk, or class II, devices the FDA proposal could limit the levels of radiation the devices emit and make other changes to their design.

The move comes in the wake of lobbying by public health and medical advocacy groups concerned with the ballooning rates of lethal skin cancers like melanoma. The incidence of such cancers has been steadily rising over the last three decades, and the Centers for Disease Control (CDC) expects over 75,000 Americans to be diagnosed with melanoma this year alone. Clearer warnings on the risks of commercial tanning by American youth is particularly important given that “people who begin tanning younger than age 35 have a 75 percent higher risk of melanoma” and the reality that less than 11 percent of tanning facilities followed FDA’s safety schedule limiting young people’s use of the beds to three times a week at most — in fact, the vast majority of such facilities “would allow teens to use their facilities all seven days for the first week.”

Several states — including Vermont, California, and New Jersey — actually have outright bans on under-18 tanning due to the associated public health risks. Maine Gov. Paul LePage (R) recently vetoed a bill that would enact the same restrictions in his state, parroting tanning bed producers’ and tanning salon owners’ argument that it could actually be riskier for kids to get their tan on in regular sunshine, which also exposes them to UV rays. Those claims were debunked in a 2010 American Association for Cancer Research study, which concluded that the more concentrated rays use in tanning beds are actually more dangerous than normal sunlight.

Health

States Take On Unregulated Pharmaceutical Facilities As House GOP Holds Back Nationwide Reform

(Credit: ABC News)

After last year’s deadly meningitis outbreak was traced to unclean conditions at a New England-area pharmaceutical mixing plant, state and federal officials called for increased oversight of the largely unregulated facilities. But as states await congressional action to give the Food and Drug Administration (FDA) and state agencies more regulatory authority over the so-called “compounders,” many have taken it upon themselves to increase facility inspections in an effort to protect public health.

Since December’s outbreak, five states — including Maryland and Virginia, which experienced fatalities linked to the incident — have already passed new laws strengthening regulation of compounding pharmacies, and another nine have legislation pending. Independent groups have also conducted over 100 inspections in several other states.

But as Politico reports, barring enhanced funding and clearer lines of FDA and state authority endorsed by Congress, there is only so much that states can do on their own:

“NECC just blew this out of the water, and there was a recognition that these guys really weren’t being overseen much at all,” said Joseph Hill, legislative director for the American Society of Health-System Pharmacists. “States realized they need to know who these compounders are, where they are operating and where they are sending product, and to provide some oversight.” [...]

Many states have been devoting the resources needed in the short term to bolster inspections, Catizone said, as they wait to see what Congress will do before passing laws of their own.

But even as states act, the steps they are taking vary. And experts say it would be difficult for them to plug the regulatory hole on their own.

“It’s partly a matter of resources,” Hill said. “You can have the perfect regulation, but if you can’t spend the time and money to give your people specialized training and send them to do inspections, the regulation won’t matter much.”

Those additional resources are particularly significant considering that inspections conducted since the outbreak have revealed that a vast number of compounding facilities violate safety guidelines, including unsanitary conditions such as rusty and moldy mixing plants.

Congressional Democrats have introduced bills that would crack down on compounders by increasing FDA funding, creating a federal database of compounding facilities, and subjecting the drug makers to a minimum level of production standards. But House Republicans have been skeptical about requests for additional resources and tighter regulations, arguing that the FDA’s past failure to prevent outbreaks such as last December’s indicates that such legislative measures would be futile. FDA director Margaret Hamburg has argued that the exact opposite is true, and that barring legislative fixes, the agency will be largely unprepared to address future crises — as will the states that have taken it on themselves to safeguard their residents’ public health.

Health

FDA Finally Reviewing Controversial Ingredient In Soap After 40 Years Of Procrastination

(Credit: Bill Hogan/Chicago Tribune)

In 1972, Congress passed a law requiring the U.S. Food and Drug Administration set guidelines for anti-bacterial chemicals commonly used in soap. In a tentative draft published in 1978, the FDA identified one such chemical, triclosan, as potentially dangerous. Yet 35 years later, the FDA still has not finalized those guidelines, and triclosan has become a common ingredient in many soaps, toothpaste, mouthwashes, household cleaners, and toys.

Now, the FDA plans to complete its long-delayed review to determine whether or not triclosan is safe. Last year, after missing its spring 2011 deadline, the agency promised to complete the review in winter 2012. It then pushed it back to February 2013. Finally, after a federal court ordered the FDA to complete the review, the agency has set a new target release for later this year. During the decades of delay, evidence of triclosan’s potentially serious health risks has piled up.

In multiple independent studies, triclosan has been shown to alter hormone regulation, increase risks of infertility, and impair muscle function in humans and animals at the cellular level. Worrying concentrations of the chemical have also appeared in breast milk and in fish near wastewater treatment plants. Moreover, the FDA itself says triclosan contributes no added benefits to conventional soap.

As the FDA drags its feet on releasing the review, some companies are taking the initiative to start phasing out the controversial chemical. Kaiser Permanente pulled triclosan soaps from its 37 hospitals, while Johnson & Johnson has committed to removing triclosan from all its products by the end of 2015. The Environmental Protection Agency is also jump-starting their six-year review of triclosan’s use as a pesticide and preservative by a decade. Once these reviews are complete, companies may have to post warnings, reduce concentrations, or eliminate the chemical entirely.

Health

Women’s Health Groups Slam Obama Administration’s Fight To Maintain Age Restrictions On Plan B

Late Wednesday evening, the Obama administration announced that it will appeal a recent court decision that ordered the FDA to make emergency contraception available to all women over the counter. Last month, U.S. Judge Edward R. Korman gave the administration 30 days to lift the current age restrictions on over-the-counter Plan B, saying the decision to require younger teenagers to obtain a prescription for the FDA-approved contraceptive amounted to “political interference.”

The Department of Justice believes Korman overstepped his authority by ordering a federal agency to change its policy without allowing more time for internal review. Earlier this week, the FDA announced that it will lower the age restriction from 17 to 15, a policy change that is unrelated to last month’s court ruling. The Obama administration’s decision to appeal is a sign that it will stand by that new rule.

But the women’s health groups that have long advocated for expanded access to emergency contraception — which prominent medical groups confirm is safe for girls of all ages — are unhappy with what they perceive as a “step backwards.” Since there is no scientific basis for age restrictions on Plan B, reproductive rights leaders argue that the White House is simply insistent on playing politics to impose an unnecessary burden on young women:

– SUSANNAH BARUCH, INTERIM PRESIDENT AND CEO OF THE REPRODUCTIVE HEALTH TECHNOLOGIES PROJECT: “This appeal takes away the promise of all women having timely access to emergency contraception. It is especially troubling in light of the Food and Drug Administration’s move yesterday to continue age restrictions and ID requirements, despite a court order to make emergency contraception accessible for women of all ages. Both announcements, particularly in tandem, highlight the administration’s corner-cutting on women’s health. It’s a sad day for women’s health when politics prevails.”

– NANCY NORTHRUP, PRESIDENT AND CEO OF THE CENTER FOR REPRODUCTIVE RIGHTS: “The federal court has made clear that these stalling tactics were based purely on politics, not science. We are deeply disappointed that just days after President Obama proclaimed his commitment to women’s reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions.”

– CECILE RICHARDS, PRESIDENT OF PLANNED PARENTHOOD FEDERATION OF AMERICA: “The Obama administration took an important step forward earlier this week by moving emergency contraception out from behind the pharmacy counter and making it available to people ages 15 and older, and we continue to believe that access should be expanded further.”

– TERRY O’NEILL, PRESIDENT OF THE NATIONAL ORGANIZATION FOR WOMEN: “The prevention of unwanted pregnancy, particularly in adolescents, should not be obstructed by politicians…President Obama should practice what he preaches.” She called the decision to appeal a “step backwards for women’s health.”

– ILYSE HOGUE, PRESIDENT OF NARAL PRO-CHOICE AMERICA: “When Judge Korman’s ruling came down, we welcomed it as an affirmation that policy can and should be driven by facts and delivered with the public health in mind. Unfortunately, today’s appeal reminds us that sometimes our leaders are out of step with the reality women face every day. We can only assume that HHS is signaling that they are satisfied with the status quo. That’s simply unacceptable.”

Conservative groups, on the other hand, applauded the decision to appeal — but still found some fault with the administration’s Plan B policy, which they believe is too lax. Marjorie Dannenfelser, the president of the anti-abortion Susan B. Anthony List, noted, “While we agree with the administration’s decision to appeal Judge Korman’s ruling, it is troubling that Secretary Sebelius is ‘satisfied’ with the FDA’s decision to endanger the lives of teen girls. Whether they are 15 or 17, teens need the protection and support that comes with parental and doctor involvement…The administration is moving in the wrong direction if they seek to set an underage standard.”

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