consumer protection

RECENT POSTS

Consumer Advocates: FDA’s Action On Vaginal Mesh ‘Too Little Too Late’

Public Citizen, the consumer advocacy group that years ago called for tighter restrictions on a type of surgical mesh used to treat pelvic organ prolapse, called the FDA’s latest proposal to increase oversight on the products “troubling both in its scope and timing.”

The group said in a statement that the government agency waited too long to act and that its recommendations may still put women at risk.

Here’s the full statement from Public Citizen’s Health Research Group Director Michael Carome on the FDA’s latest proposal:

Public Citizen welcomes…[the] long-overdue issuance of a proposed order by the U.S. Food and Drug Administration (FDA) that, if finalized, would reclassify surgical mesh for transvaginal pelvic repair organ prolapse (POP) from a moderate-risk device (class II) to a high-risk device (class III). This would subject these devices to a more rigorous approval process that would require manufacturers to submit to the agency premarket approval applications with evidence from clinical trials that the devices are safe and effective. Such an order would implement one of three actions requested in Public Citizen’s August 25, 2011, petition to the FDA, which also requested an immediate ban and recall of all such devices currently on the market.

(wikimedia commons)

(wikimedia commons)

However, the FDA’s action today is troubling both in its scope and timing. First, the agency acknowledged that the safety and effectiveness of surgical mesh for transvaginal repair of POP has not been established and that these devices frequently cause serious adverse events. But the agency has taken no action to immediately remove currently available products from the market, as we requested in our petition, or to warn physicians and patients to stop using these devices.

Second, it is disturbing that the agency has taken so long to begin the regulatory process to reclassify surgical mesh for transvaginal repair of POP Continue reading

Diet Pill Dilemma: Why Is FDA Approving Drugs When Europe Isn’t?

By Karen Weintraub
Guest Contributor

We’ve all dreamt of popping a pill to help us safely lose weight, or at least eat that chocolate cake without guilt. But alas, even though the Food and Drug Administration has approved two new diet drugs in recent months, that dream probably isn’t any closer to reality.

2day929/flickr

2day929/flickr

In the current issue of the BMJ (formerly the British Medical Journal), Sidney Wolfe, founder of the advocacy group Public Citizen, slams the FDA for approving the drugs – lorcaserin (US brand name Belviq) and topiramate (called Qsymia). The FDA’s European counterpart rejected both of them because of heart risks that turned up during preliminary trials.

The FDA decided that the risks were relatively small and ordered the manufacturers to look for problems once they are on the market – basically, approving the drugs now and worrying later if they prove dangerous. Buyer beware.

The problem, Wolfe explained in a phone interview from Washington where he is preparing to testify at a National Institutes of Health meeting tomorrow, is that the reasons for hunger are complex and connected to many biological systems.

“When you give a drug powerful enough to effect hunger it is also going to affect other systems of the body,” most often the heart, he said. Continue reading

Health Care Law Coming Out Day: Are You Feeling Reformed?

Kaiser Health News has a great big roundup of stories today, marking the day that the first set of consumer protections take effect, six months after the enactment of national health care reform.

We want to know how the new law is affecting you. Are you now able to get insurance even though you have pre-existing conditions? Are your twenty-something kids now covered under your policy? Have you started getting preventative care without co-pays? Tell us if the law is filtering into your lives, and how.