Physicians who prescribe hormones containing estriol have grown concerned about the FDA’s so-called “abbreviated” Investigational New Drug (IND) application for estriol. The process will effectively ban most physicians from prescribing a medication they consider best for their patients.

The IND places a significant financial burden on physicians, most notably by requiring them to submit applications to an Institutional Review Boards (IRB). Submitting necessary documentation and contracting for a private IRB can easily cost between $10,000 and $25,000 and can take months.

The FDA’s new policy threatens the access of this important medication for my patients who rely on hormones containing estriol to relieve the symptoms of menopause. It could force them off of treatment their doctors have deemed necessary, and would either deny them treatment or subject them to the unnecessary expense and inconvenience of a new treatment regime.

Millions of women have been prescribed estriol and have used it safely for decades.

Last year, the FDA issued new comprehensive regulations for sunscreens, promising consumers more informative labels. But consumers should not expect to see the new labels any time soon. The agency recently said that it has not yet set a date to make the updated rules final, let alone implement them, because it has been inundated with thousands of comments.

The delay is particularly galling to consumer advocates, who blame sunscreen manufacturers for filibustering, and the FDA for inertia.

The new rules include more detailed labeling that would indicate efficacy against ultraviolet A and ultraviolet B radiation. The current SPF numbering system, which only accounts for UVB rays, has been in place since 1978.

In most recessions, drugs are usually considered a bright spot for marketers. Consumers may skimp on food, fuel and clothes, but the business of health often benefits from “nondiscretionary” spending. But that is not the case this time round.

Marketers are predicting an overall decline through 2011, which would be the first setback the business has ever seen.

The decline is unrelated to the economic woes of the rest of the country. Instead, it is caused by an unusual confluence of events:

• Many patents have expired or are about to expire
• The FDA has become more skittish about approving new drugs
• Drug companies’ R&D pipelines won’t have any major new launches until 2011
• The growing number of uninsured Americans is impacting the total number of prescriptions written

Analysts expect to see more drug marketing money go online or into CRM programs, which are cheaper than commercials.

For many years, the food industry pressured the U.S. government to limit the paperwork companies needed to keep in order to help U.S. health investigators quickly trace produce that sickens consumers. The White House, in response, killed a plan to require the industry to maintain electronic tracking records that could be reviewed easily during a crisis.

The result has been a paper record-keeping system that has slowed investigators, causing estimated business losses of $250 million to the food industry as food borne illnesses remain unresolved. So far, nearly 1,300 people in 43 states and Canada have been sickened by salmonella since April.

In 2003 and 2004, the White House agreed to dilute record-keeping proposals by FDA safety experts. Companies complained the proposals were too burdensome and costly.

“If the FDA had been given the resources and authority years ago that it asked for to solve these kinds of problems, I think we would have solved this already,” said William Hubbard, a former FDA associate commissioner.

Posted for Meredith Wadman A gray, sinister-looking picture of US Food and Drug Administration (FDA) commissioner Andrew von Eschenbach appeared in a full-page ad in Tuesday’s Washington Post. “Meet Andrew von Eschenbach,” the caption ran. “On His Watch, `FDA’ Stands for `Federal Dog Abuse.’” The ad, placed by People for the Ethical Treatment of Animals (PETA) goes on to explain, atop a smaller picture of an adorable puppy, that “because the FDA guidelines are antiquated, dogs are still force