Later On

A blog written for those whose interests more or less match mine.

One reason the FDA is ineffectual

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Sy Mukherjee at ThinkProgress:

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 agencyinvestigates 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 diseasestrokeobesityhypertension, 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.

But an outright ban on any of those substances (other than trans fats) is impossible — and undesirable — since the majority of food items require them in at least some amount. Rather, it’s excess consumption that makes the substances potentially dangerous. That’s where the FDA can step in by issuing regulatory rules that either set targets or impose reductions in harmful food content. But that’s also where they meet their greatest obstacle: the powerful food lobby.

“It’s corporate power,” said Dr. Michael Jacobson, executive director of the Center for Science in the Public Interest (CSPI), in an interview with ThinkProgress. “For something like salt, or partially hydrogenated oil (trans fat), or sugar, there’s huge industries behind those substances. First there’s the manufacturers themselves, and then there’s the food companies that use their products. All those companies would be discomfited by an FDA ban or regulation, so they can then go to Congress and say, ‘Look at what the FDA is trying to do! It’s killing our business.’” Congress can then put pressure on the FDA by “cutting [its] appropriations or putting a rider in an FDA bill preventing it from imposing certain regulations,” according to Dr. Jacobson.

That sort of arm-twisting tends to work — even when an FDA action is simply advisory and lacks enforcement power. For instance, Dr. Jacobson explained to ThinkProgress that in the 1990s, “[t]he government came up with draft voluntary guidelines for foods marketed to young children. And the Grocery Manufacturers Association said its highest priority was to kill the voluntary guidelines –- and this wasn’t even a regulation, just guidelines!” Congress ended up siding with the grocery manufacturers over the children. “The public health becomes a side issue,” said Dr. Jacobson.

And even when the FDA succeeds in taking regulatory action, it can get held up for years — and even decades — by lawsuits and lobbying campaigns launched by Big Food companies, as well as . . .

Continue reading.

I found it interesting that corporations fight even voluntary guidelines: they want no restrictions whatsoever, but to do as they please. And it’s pretty clear that public health and public safety count for nothing with corporations and Congress (in general).

Of course, the FDA is ineffectual for other reasons—such as falling under control of the industries it is supposed to regulate. Aviva Shen reports at ThinkProgress:

In a fiery decision on Friday, U.S. District Judge Edward Korman denied the Obama administration’s motion to delay an order to immediately allow over-the-counter access to emergency contraception to women of all ages. After Korman initially ordered in April that the so-called “morning-after pill” be available to all women and girls without a prescription, the FDA instead decided to lower the age limit to teens 15 and up rather than 17. However, those 15- and 16-year-olds will only have over-the-counter access to one brand of emergency contraception pill, Teva Pharmaceutical’s Plan B One-Step, thanks to what Korman called a “sweetheart arrangement” between the FDA and Teva.

Blasting the Obama administration’s argument as “an insult to the intelligence of women,” Korman attacked the FDA’s decision to lower the age restriction for Plan B rather than comply with his order to allow all women access to any brand of emergency contraception. The judge accused the administration of delaying his ruling so as to give Teva Pharmaceutical sole access to the market of 15- to 17-year olds without a prescription. Generic versions of Plan B, meanwhile, will stay behind the pharmacy counter for this age group.

Korman also noted that Teva will drive up the price of the pill now that it has a monopoly on young women in need:

While this proposal was a boon to Teva, it did little to eliminate the practical obstructions in obtaining emergency contraception to women of child-bearing age whether over or under age 15. On the contrary, Teva will use its privileged marketing status and exclusivity to increase the cost of the drug. The price of Plan B One-Step under the new marketing regime is expected to be $60, significantly more than the one- or two-pill generic version, and could conceivably go higher, if only to accommodate the more expensive packing, age-verification tags, and anti-theft technology that the new marketing arrangement would require.

As Teva profits from the Obama administration’s arbitrary age restriction, the burden on women seeking emergency contraception will only grow larger. Younger teens and undocumented women unable to prove their age with government-issued ID will still not have access, and may not be able to afford the new cost. As Korman points out, the Teva-FDA deal still requires Plan B to be sold over the counter at stores with on-site pharmacies, even though many women do not live near such facilities. The decision also cites a survey of 943 pharmacies in 5 cities, which found that only 4.7 percent stayed open 24 hours. Given the time-sensitive and often urgent need for emergency contraception, limiting the hours and locations where women can buy the drug could have serious consequences.

Moreover, there is no medical reason to limit access to the morning-after pill. Despite the Obama administration’s concern that it could be “dangerous”  to young teens, an enormous body of research has demonstrated emergency contraception is safer than aspirin for women of all ages.

Obama: the continuing disappointment.

Written by LeisureGuy

11 May 2013 at 8:44 am

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