Showing posts with label Fda Approval. Show all posts
Showing posts with label Fda Approval. Show all posts

Sunday, 1 April 2012

Medical Device Marketing-Marketing Campaign-Consumer Reports-Medical Research-Medical Devices

Medical Device Marketing Don't Need No Stinkin' ROI!

"Standards for devices exist, they just don't make sense," industry critic Dr. Diana Zuckerman, president of the National Research Center for Women & Families, said in a Consumer Reports release (also read this CBS report "Investigation: Most medical devices implanted in patients without testing"; see video below).
"An investigation by Consumer Reports, which included interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA, shows the following areas of concern:

  • Medical devices often aren’t tested before they come on the market. “What they’re doing is conducting clinical trials on the American public,” says Dan Walter, a political consultant from Maryland. His wife was left with heart and cognitive damage from a specialty catheter, cleared without testing, that malfunctioned during a procedure to treat an abnormal heartbeat.
  • There’s no systematic way for the government, researchers, or patients to spot or learn about problems with devices. “A coffeemaker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn’t,” Zuckerman says. “Your doctor is supposed to notify you of a problem but may not be able to if he has retired or passed away.”
  • Without major changes in the system, there’s not much that patients can do to protect themselves.
According to Consumer Reports, the majority of medical implants are not tested to make sure they are safe. Most of the time device manufacturers only need to pay the Food and Drug Administration (FDA) a fee of about $4,000 with minimal testing in order to get approval for marketing. Compared to drug approval, this is a walk in the park.
In fact, sometimes device manufacturers bypass this minimal approval process altogether as did Johnson and Johnson's Ethicon unit (see "J&J Marketed Medical Device Without FDA Approval").
Not only is the approval of medical devices by FDA more lax than the process used to approve drugs, medical device marketing is worlds apart from Rx drug marketing as I learned from a presentation made by a Medtronic marketing VP. The presentation focused on a case study of a marketing campaign for the Prestige Cervical Disc.
That case study showed that out of an estimated 5 million spine surgery candidates (patients) in the US, Medtronic only needed to capture 125 of them to break even on a very successful marketing campaign that reached 6.2 million local TV viewers, 80.5 million radio (especially satellite radio) listeners, 4 million print readers, and 73 million Internet browsers. (Get more details about that case study by downloading this Pharma Marketing News article: "Medical Device Marketing: Worlds Apart from Rx Drug Marketing"; use discount code 'DEV444' BEFORE April 15, 2012 to get it FREE!).
While drug advertisers would sweat and moan over whether such a campaign would have a positive ROI (return on investment), medical device marketersdon't need to worry about no stinkin' ROI because of such low numbers of conversions required AND also because very little resources need to go into premarket testing in order to get FDA approval. read more..

Friday, 23 March 2012

International Commercial Partnership-Alexza Pharmaceuticals-Public Offering-Fda Approval

Alexza's vaporized anti-psychotic threatened by dwindling cash

Even with a beefed up international commercial partnership, a public offering, restructuring and layoffs, Alexza Pharmaceuticals ($ALXA) has disclosed that its cash could run out by year-end. And so stakes increase even further over the FDA's pending evaluation of Adasuve, the company's inhaled, fast-acting, vaporized formulation of the antipsychotic drug loxapine.Mountain View, CA-based Alexza just can't catch a break. As of Dec. 31, the company said it had just $16.9 million in cash, equivalents and securities on hand. And after taking steps earlier this year to raise more than $20 million in a public offering, slash 38% of its workforce (29 jobs), and boost its international commercial partnership stake with Grupo Ferrer, the company reported that current cash burn rates will only carry it through the 2012 fourth quarter.Alexza is struggling to gain FDA approval for Adasuve, which improves on the long-used oral version of loxapine to treat adults for schizophrenia-related agitation or bipolar I disorder. The drug is housed in the company's Staccato inhalation device, which delivers a vapor directly to the lungs and subsequently reaches the bloodstream quickly.We learned in January that the FDA delayed its review deadline from Feb. 4 to May 4, in order to review how Alexza is addressing changes to safety and dosage guidelines recommended by an FDA panel of experts in December. Its decision, clearly, could make or break the company. So May 4 could be Doomsday or Christmas. An FDA-approved Adasuve would compete with injectable drugs made by companies including Bristol-Myers Squibb ($BMY) and Eli Lilly ($LLY).Alexza booked a $9.7 million net loss during the fiscal 2011 fourth quarter and $40.5 million net loss for the fiscal year that ended Dec. 31.- read the financials releaseRelated Articles:
Alexza's Adasuve slapped with delayed FDA review
Alexza layoffs looming read more..