Food and Drug Administration

New FDA Guidelines Could Revive Debate Over ‘Female Viagra’
FDA sent Addyi’s application back to its manufacturer twice for changes

A draft guidance that the Food and Drug Administration published Tuesday could revive a debate about a drug approved last year to enhance the female libido. At the time of the approval, many observers questioned the FDA’s decision and doubted that the drug actually works. Now, some of the same critics are wondering whether or not the product, called Addyi and nicknamed the “female Viagra,” would even live up to the agency’s newly proposed criteria.

For instance, the draft guidance suggests that patients participating in clinical trials should frequently record key signs and symptoms “to minimize inaccurate responses resulting from problems” with a patient’s ability to recall past feelings. The guidance doesn’t specify just how long the recall period should be, but it hints that a shorter one is more desirable. “The longer recall period may increase noise in the assessment making it more difficult to detect or interpret change during a trial. With a longer recall, it is also possible that subject recollection could be more heavily influenced by other experiences or by more recent experiences,” the guidance says.

FDA Approval Changes Could Affect Drug Prices
Regulators aim for accelerated timeline for completing applications

Upcoming changes to the Food and Drug Administration’s reviews for generic drugs could have an impact on drug prices if they help introduce more competition to the market.

In separate public meetings on Thursday and Friday, FDA officials discussed their plans for renewing the programs that charge generic drugmakers a fee to go through the application process. The FDA has been scrutinized for aspects of its generic approval programs that critics contend prevent cheaper generic therapies from coming to market.

New Biosimilars Highlight Need for FDA Action
Lawmakers are frustrated that so few have hit the market

Texas Rep. Joe L. Barton said he was concerned over the FDA's slow pace in approving new biosimilars. (Bill Clark/CQ Roll Call file photo)

An advisory committee to the Food and Drug Administration last week recommended the approval of generic versions of two expensive arthritis drugs, which if approved by the agency could be good news for health care spending and patients burdened by high drug prices.  

But the action served as a reminder that the agency still must issue key guidelines on how to evaluate whether generic drugs in this class are fully interchangeable with their original products.  

Democrats Try Again to Lift FDA Blood Donor Ban for Gays
Lawmakers say policy perpetuates stereotype but chances for change may be slim

House Democrats are urging the FDA once again to abandon its practice of banning sexually active gay men from donating blood after the Orlando shooting. (Bill Clark/CQ Roll Call File Photo)

House Democrats said Tuesday they may try to pass legislation to end a Food and Drug Administration policy that prevents gay and bisexual men from donating blood unless they have been celibate for one year.  

Such a measure may be difficult to get past Republicans. Even President Barack Obama’s administration has been reluctant to urge the FDA to change its policy, saying that the decision should solely be based on scientific evidence provided by the agency.  

House Dems Urge FDA to Lift Blood Donation Ban
Six members say "unrealistic" policy furthers stigma

The FDA recently lifted a ban that prohibited gay men from donating blood, a policy that dated back to the AIDS epidemic. ( Bill Clark/CQ Roll Call File Photo)

Six House Democrats on Tuesday asked the Food and Drug Administration to lift what they called an "unrealistic" ban on sexually active gay men from donating blood that furthers an old stigma.  

"[T]he 12-month deferral policy, which suggests that the sexual relationships of [gay] men and transgender women inherently pose a risk of HIV transmission, furthers a stigma that we have persistently fought to eliminate," the lawmakers wrote in a letter to FDA Commissioner Robert D. Califf. "The FDA questionnaire should reflect risk-based behaviors as opposed to sexual orientation."