My advisors tell me to keep working the system, to keep the door cracked open by giving FDA officials opportunities to "save face" and encourage a new drug application for eteplirsen. But I cannot allow any more time to go by.
The global community's response to sexual dysfunction should be equal for women and men, but it is not. This year marks 16 years since the introduction of Viagra. Today, the market includes more than 20 drugs to address male sexual dysfunction -- and not a single one for women.
This week, 23andMe, the Google-backed DTC genetic test company, stunned many observers by agreeing to stop sales of its $99 genetic test kit online, saying it will now release only ancestry information and raw data without interpretation.
It is perfectly legal and common for physicians to prescribe medication and medical devices for "off-label" use. But the FDA prohibits manufacturers from directly promoting the unapproved use of their products.
As time went by during my daughter Alexis' long thirty-three month battle, we found out that her tumor was growing. We found ourselves in Manhattan seeking to gain enrollment in what looked to be a potentially promising trial. But after preliminary tests we were told that Alexis was ineligible.
For as welcome as the new food safety programs are, the FDA is still plagued with problems. It moves at a glacial pace in the face of pressing health hazards, like its three-decade-long refusal to act on its own findings that the use of antibiotics in livestock feed threatens human health.
At stake is whether medical devices that are put in your body, cardiac stents, heart valves, knee and hip implants, among others, will be subject to safety tests in humans before they are approved by the FDA.