The FDA’s recent enforcement action against genetic testing firm 23andme rattled health-tech executives. (Hong Chang Bum/Flickr)
By Christina Farr
Health care entrepreneurs are a different breed than most entrepreneurs. Rather than hunkering down to build a cool product, they need to think about regulation and red tape — right from the start.
Ignoring the FDA and pushing ahead with a product is not a viable option.
As boring as it may sound, health-tech founders need to develop a relationship with the U.S. Food and Drug Administration (FDA). This process might drag on for some time, as this authority has the unenviable job of overseeing an explosion of new medical technology, whether it’s a new electronic health record or a device that turns your smartphone into an ear scope.
As the recent enforcement action against genetic testing firm 23andMe demonstrated, ignoring the FDA and pushing ahead with a product is not a viable option.
In recent years, Silicon Valley’s entrepreneurs have become increasingly critical, attacking the agency’s antiquated processes in a string of interviews and op-eds. Continue reading
By Kamal Menghrajani
Last month the Food and Drug Administration warned 19 doctors and clinics that counterfeit vials of the chemotherapy drug Avastin had been identified in the U.S. Most of those doctors were in California. Today the Wall Street Journal reports that the FDA is investigating two businessmen from Canada who may be the source of these vials. One of them had admitted to shipping fake Avastin last year, although he says he did not know the vials contained counterfeit drugs. While it is generally illegal for anyone but the manufacturer to import prescription drugs into the U.S., it happens frequently and has proven difficult to police, the Journal reports.
“We’re deeply horrified by this counterfeit [product] being sold by one of my companies,” said Thomas Haughton, a Canadian citizen who runs a network of drug distributors that sell to U.S. doctors. At the same time he said that his business operated legally. “We’re doing everything we can to be sure that this never happens again.”
While experts say most U.S. drugs are safe, the probe may raise new concerns about the weakly regulated gray market in foreign drugs aimed at U.S. patients. The importation of foreign drugs by third parties, which takes advantage of the large price differential between the U.S. market and others abroad, is believed to represent a small but growing portion of the $300 billion U.S. prescription pharmaceutical business.
Stories of critical drug shortages–including cancer drugs–have been making news for months. Now the Food and Drug Administration is announcing that replacement supplies of two of those drugs, Doxil and methotrexate, should be available within weeks.
Both drugs are used to treat cancer. Methotrexate is used for many conditions, but of particular concern is its use for a type of childhood leukemia. If a child does not get the drug, the cancer can easily recur.
As the New York Times reports, some experts say the new supplies are only a temporary solution: Continue reading
By: Sarah Varney
The announcement by the Food and Drug Administration last week that sixteen California clinics and physicians were sold bogus vials of the cancer drug Avastin did not surprise regulators and researchers who study the counterfeit drug trade.
Indeed, it was after fake AIDS drugs were discovered in California that state legislators passed the “e-pedigree law” mandating that all prescription drugs carry an electronic tag. The tag could be scanned to show where the drug was first manufactured and every stop along its way to market.
Since the law passed in 2004, biotech and pharmaceutical trade groups fought to delay its implementation. They argued, successfully, that the electronic track-and-trace system would up-end global drug manufacturing. Continue reading
By Kamal Menghrajani
A counterfeit version of the cancer drug Avastin may have made its way into clinics here in California. The medicine is used to treat colon, lung, and other cancers, but several physicians may have unwittingly been giving patients a useless knock-off.
You may remember Avastin because it was considered a blockbuster drug for breast cancer treatment. That was until November of last year, when the Food and Drug Administration (FDA) pulled its approval for treating the disease. However, Avastin is still widely used for other types of cancer.
Earlier this month, the FDA sent letters to 19 doctors around the country warning that they may have fake Avastin. Sixteen of these physicians are here in California, all of them in Southern California.
The FDA says these clinics purchased the medicine from a foreign supplier under the names “Quality Specialty Products” or “Montana Health Care Solutions.” Volunteer Distribution, a company based in Tennessee, funneled the fake vials out to clinics. The company was not licensed by drugmaker Genentech to provide Avastin, and some doctors’ offices were fooled. Continue reading
Dr. Margaret Hamburg, FDA Commissioner. (US Mission Geneva: Flickr)
Last week, the big story may have been the Susan G. Komen Foundation’s flip-flopping over funding Planned Parenthood. But coming in a close second (at least here at the health desk) was the call for regulating sugar in the same way alcohol and tobacco are. The argument was made by UC San Francisco researchers in the journal Nature. They laid out the science that sugar is behind many of the chronic maladies we see today–diabetes, heart disease and high blood pressure.
Today FDA Commissioner Margaret Hamburg was a guest on KQED’s Forum. Host Michael Krasny asked her if sugar should be removed from the FDA’s “GRAS” category–that’s for Generally Recognized as Safe. Not surprisingly, the Commissioner did not announce imminent action. She said she did have a chance to “look quickly at the initial report” and that “we’ll look very seriously at any new data that’s presented.” Continue reading
FDA Commissioner Dr. Margaret Hamburg announced this morning that the agency is revoking approval of Avastin as a treatment for metastatic breast cancer. The Agency had “fast tracked” the approval of the drug in 2008, based on results of one study, but had requested additional research. Those follow up studies did not support the initial findings, the FDA has decided.
NPR’s Shots blog reports on today’s events as well as the history behind the decision.
Hamburg lays out the reasoning for the rare move in a 69-page decision. In a news briefing Friday morning, she said of the drug: “It’s clear there is no benefit to breast cancer patients that would justify its risks.” She said she didn’t “come to this decision lightly but as a result of a rigorous process.”
Roche’s Genentech unit, maker of Avastin said in a statement, “We are disappointed with this outcome.” The company said it will help women “who may be facing obstacles to receiving their treatment” with the drug through a patient-support program. It’s also continuing research on the use of the drug for breast cancer.