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Bill Hawkins, Chairman & CEO of Medtronic, was an invited guest at the Clinton Global Initiative meeting held in New York City. During this interview with Maria Bartiromo, he discusses the health of the medical device industry, Medtronic’s latest stent product and patient responsibility in taking charge of their own healthcare.
The FDA has been releasing reports from study groups as to how best overhaul the approval process for medical devices. One report focuses on ways to strengthen and clarify the 510(k) process for devices that do not need to undergo a full premarket approval (PMA) review. The reports can be found here.
Last week, the Advanced Medical Technology Association (AdvaMed) said in a statement that it was reviewing the FDA’s recommendations. The group said it was pleased to note on first reading, though, that the 510(k) report incorporates AdvaMed recommendations on targeting special requirements for a small subset of class II 510(k) devices.
Now, however, AdvaMed has raised objections to some of the proposals found in the reports. One FDA proposal is to establish the Class IIb category for medium-risk devices. According to the report, “delineating between Class IIa & Class IIb would not reconfigure the current, three-tiered device classification system established by statute; it would represent only an administrative distinction.”
But Advamed believes the new category could lead to the extensive reclassification of products and pose additional requirements to device firms. According to AdvaMed EVP Janet Trunzo, “The FDA’s proposal goes beyond what we were thinking.”
So will this be the big topic of conversation amongst leading device CEO’s during next months conference in Washington DC?
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Seattle Genetics CEO Clay Siegall joins CNBC to discuss the outcome of key clinical trial for the company’s lead drug candidate for oncology. The company’s novel blood cancer treatment performed well in a Phase III trial, easily surpassing expectations. The drug, called bentuximab vedotin, shrank tumors in three-quarters of patients with Hodgkin lymphoma. It is a part of a next-generation of biotech therapies that aims to bolster chemotherapy’s effectiveness while reducing its damaging side effects.
The drug has orphan drug status in the U.S. and Europe, and the company plans to file for FDA approval in the first half of 2011. Seattle Genetics is also studying its use in earlier forms of the disease and in other blood cancers.
The (FDA) has approved the first oral drug for treating the most common form of multiple sclerosis. Novartis received FDA advisory committee approval by a unanimous vote in June, and now the drug has the FDA’s approval for patient treatment. Unlike current MS drugs which are given by injections or infusion, this new drug, called Gilenya (fingolimod) comes in a convenient daily capsule dosage form.
Multiple Sclerosis affects about 2.5 million people in the world & over 400,000 in the United States alone. What causes MS is still not known & Gilenya is not a cure but a treatment to lessen the progression and symptoms of MS. According to Novartis, Gilenya can cut the relapse rate of patients by more than 60%.
October 4th is a landmark day for the medical device industry in the United States. See, 10/4 is the final day for the public to present feedback to the agency regarding some 70+ changes to be applied to the 510(k) approval process. Once past, the FDA will begin to make a decision.
In advance, AdvaMed has released a study hoping to minimize any changes. According to the study, less than 1 percent of devices cleared since 1998 were involved in significant, Class I recalls that could cause serious injury or death.
Proposed change has resulted from delays and inconsistencies in the program, as witnessed by the industry itself. Most agree that the approval process is long overdue for a review, yet AdvaMed executives are wary of wholesale change: “Reform of the 510(k) program is appropriate, but you need scalpel, not a meat axe.”
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Investigators and Congress are turning up the heat on Johnson & Johnson. The company’s widespread product recalls have been well documented. However, details are beginning to emerge as to how J&J managed the crisis.
Apparently, J&J’s preference was to quietly remove defective products from store shelves. They executed this plan through private contractors hired to buy up entire store inventories as ‘customers’ rather than issue a formal public recall. However, now there is a debate as to whether the FDA knew about it.
The House Committee on Oversight and Government Reform on Tuesday said it had obtained an email in which an executive of J&J’s McNeil consumer medicines unit described an agreement with the FDA authorizing J&J to conduct an unpublicized recall of adult Motrin: “We have negotiated agreement with FDA not to formally conduct a recall for Motrin but rather conduct a ‘soft market withdrawal.’ This is a major win for us as it limits the press that will be seen.”
On Tuesday the FDA issued a statement again maintaining that the agency was not aware of and had not signed off on McNeil’s “phantom recall” of Motrin. J&J executives, led by Consumer Head Collen Goggins, told lawmakers during a Congressional hearing in May that the company did not try to hide its Motrin recall plans from the FDA. Mrs. Goggins has since announced her retirement and departure from the company.
So what’s next? Late Tuesday, the committee requested that J&J deliver a copy of an alleged agreement between McNeil and the FDA that permitted McNeil to forego a formal recall of the Motrin product and instead conduct a ‘soft market withdrawal.’ J&J CEO William Weldon, was given until Wednesday to provide the proof. Lawyers for J&J responded late last night that no formal documents exist to validate such a claim but that normal FDA practices would not require such documentation. Simply put, both J&J or FDA are in the crosshairs of Congressional investigators as their stories conflict.
This story is far from over and big questions are looming from those across the industry. Will any criminal charges stem from this investigation? Will Weldon be called to Capitol Hill to testify? And can he survive as CEO of J&J as more details come to light?
As a point of reference, we are reposting Weldon’s last TV interview led by Mario Barturomo from CNBC during which they discuss the recall.
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Want to understand the scale required to succeed in the generic pharmaceutical market? It’s a completely different game from the ethical, branded pharmaceutical industry we all know so well.
Fractionalized prices & razor thin margins demand extreme volume. Mylan Labs is expected to launch over 500 new products this year with a pipeline that includes another 1500 drugs. Raise your hand if you knew that 1 out of every 12 drugs in the United States is a Mylan drug?
The FDA has been managing a streak of rejections for weight loss medications, including a panel vote against Arena Pharmaceuticals’ drug lorcaserin. Panelists raised concerns about tumors seen in rats in pre-clinical testing of the drug offset by only modest benefits. The vote is a major setback for San Diego-based Arena, which was hoping for their first product approval and to be the first of three competing products to market. In July, the same FDA panel voted against recommending approval for Vivus’s product Qnexa due to safety concerns. Orexigen Therapeutics will have its own drug reviewed at a meeting in December.
Following the vote, the panel chair, Dr. Abraham Thomas, suggested that the FDA raise the bar on weight loss drugs, of which there are only three approved in the US. Earlier in the week the same panel was split on whether to withdraw Abbott Lab’s diet pill Meridia, which has been linked to heart attack & stroke. European regulators banned the drug earlier this year.
The medical device industry is shifting and entering a period of deflation after years of rising prices. This according to Bill Hawkins, the CEO of Medtronic, who predicts the market prices for medical devices to decline 2 percent to 3 percent driven by healthcare reform and sluggish demand.
From an interview with Reuters: “We have adjusted our business model” Hawkins said. “We’ve got certain cost reduction programs that have enabled us to manage our margins pretty well in this environment, and even with a 2 to 3 percent sort of decline going forward, we think we can maintain our margins.”
Medical device makers historically have passed on price increases by introducing new and improved products that could command a higher price tag. So are we now witnessing a fundamental shift in the market, as Hawkins predicts?
Such is the argument of Matt Bowman, an op-ed contributor to CNN, who compares embryonic stem cell technology to dinosaurs, bulky TV sets, BetaMax videotapes, and a $10,000 toilet seat?
Bowman is not a scientist but a lawyer, which should make all of us nervous. Yet his argument is sound, that science has made embryonic stem cell research obsolete. His solution? Stop debating the issue and move onto stem cell technology that works, specifically induced pluripotent stem cells (iPSCs). They “do all the things embryonic stem cells do” and don’t involve human embryos.
Read the article, then give us your opinion. Agree or disagree?
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