Latest Drugwonks' Blog
Current law requires the FDA to clear a device for sale if it’s “substantially equivalent” to a past device, known as a predicate. Markey’s bill would let the agency say no if the predicate, or past predicates in a series of equivalent devices, were removed from the market or if the agency were in the process of pulling it. It also would require companies to explain why their products are different from recalled versions.
The legislation also requires the FDA to review previously cleared products to determine whether any have recalls in their “device lineage.” A report would be due to Congress within three years.
Manufacturers “share Congressman Markey’s interest in ensuring the safety and effectiveness of medical devices,” said Wonderful Wanda Moebius, of the Advanced Medical Technology Association. “However, we believe FDA already has abundant authority to carry out its mandate and the burdensome provisions” in the bill “will not contribute to patient safety.”
In another piece of proposed legislation, U.S. Senators Bob Casey and John McCain introduced a bill that they said would streamline approvals. The legislation would ease the “burdensome review” the FDA requires to see if a new product is similar to one already on the market, the two men said in a statement.
“The FDA’s current approval process for medical devices can be cumbersome, inconsistent and far too lengthy for patients who need innovative technologies and for the companies that develop them,‘‘ said McCain, an Arizona Republican. Casey, a Democrat, is from Pennsylvania.
The bill would also address safety issues by ensuring that medical devices on the market before current safety rules existed are properly classified in a timely manner.
The plan, drafted by Democratic Senator Kay Hagan of North Carolina, was supported by biotechnology companies to speed up approvals and make the process less expensive. It would have created a program with the flexibility to allow drugs to be cleared based on any testing that shows they may be effective. This may include early trial results, interim data and use of so-called biomarkers that measure the effects of a molecule on biological functions linked to a disease.
The unusual dispute pitted biotechnology companies struggling to finance extensive trials against larger drugmakers who often trade financial aid in return for sharing sales later, said Erik Gordon, a business professor at the University of Michigan in Ann Arbor.
“Smaller biotech companies often can’t raise enough money on their own to do the currently-required safety trials, so they want to dilute the rules to let them get approvals without having to give big pharma a cut of the action in return,” said Gordon, who is based in Ann Arbor, in an e-mail. “Big pharma says ‘don’t dilute safety measures for new drugs.’ That sounds better than ‘we want to keep our cut of the action.’”
I don't agree with Gordon. He assumes that small and big firms have different interests. In fact, the larger firms are partnering with or buying smaller biotech companies to sustain product development. Why would a company invest in a product that will go through the FDA faster only to oppose reforms that would slow down approval?
Rather, larger companies view new approval measures and endpoints as causing uncertainty about how FDA will respond. Smaller companies see the regulatory path as risky to begin with and regard specific requirements to approve based on a number of measures as reducing uncertainty.
It's a difference of perspectives, both of which have merit and are not at odds with the other. I tend to side with the small companies and favor approval benchmarks that are based on a variety of response measures and post market experience. But companies of all sizes and disease foci want to get highly effective products to market more quickly.
My question is: how do we insure that what a product does -- as well as it's risks and benefits -- reflect consumer values more directly?
You can read the entire article here: http://www.businessweek.com/news/2012-02-02/drugmakers-upset-approval-system-plan-biotechs-sought.html
Representative Brett Guthrie (R-KY) introduced a bill (H.R. 3827) that would repeal the Patient-Centered Outcomes Research Institute and funding for comparative effectiveness research. The bill was referred to the Committee on Ways and Means, the Committee on Appropriations, the Committee on the Budget, and the Committee on Energy and Commerce. It was co-sponsored by Reps. Dan Benishek (R-Mich.), Joe Barton (R-Texas), Marsha Blackburn (R-Tenn.), Cathy McMorris Rodgers (R-Wash.) and Mike Rogers (R-Mich.).
Other feautres of the study that now characterize most AHRQ 'research.'
No mention of genetic tests or variations that can stratify and optimize treatment.
Conducted by the same people who dole out money to other AHRQ grantees and sit on the PCORI board and who also sit on CER boards of HMOs. (Naomi Aronson). If someone from a device or drug company was a co-author of a study funded by an agency whose decisions they would derive benefit from, Merrill Goozner and Gary Schwitzer (the wholly owned subsidiary of Health Dialog) would mutate into another life form. Oh, I forgot to mention that AHRQ is also hiring drug reps to peddle this stuff to doctors and hospitals.
How about some oversight on AHRQ's activities en route to cutting its budget or reordering it's mission?
http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=945
NPC should be commended for its pathbreaking investment in studies that seek to make medicine truly patient-centered. Here's a link to the NPC press release describing the research:
http://www.npcnow.org/Public/Newsroom/Press_Releases/2012pr/2012five_research_projects_pr.aspx
-- John Adams
On the last working day of the year (December 30, 2011), the FDA approved Prevnar 13 (a pneumococcal 13-valent conjugate vaccine) for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae. In fact, the new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses.
(The Centers for Disease Control and Prevention reports that 5,000 adults die from pneumonia every year.)
And to drive home the importance of this action, the FDA issued a press statement on the approval before heading home for the long weekend:
“According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research. “Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group.”
Not so fast.
Although it’s quite a high hurdle to have a vaccine approved by the FDA (and appropriately so), it’s not the final hurdle in getting it to patients. That final hurdle resides with the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP).
ACIP’s charge is to “provide advice and guidance to the Secretary, HHS, the Assistant Secretary for Health, and the Director, CDC, regarding the most appropriate selection of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population.”
The ACIP meets three times a year, and during these meetings newly licensed vaccines are discussed and a vote is taken to include (or not include) the new vaccine on the adult immunization schedule. ACIP’s recommendations become a basis for reimbursement by public and private payers who will pay for vaccinations that are part of the committee’s recommendation -- but generally not otherwise. The CDC schedule plays an important gatekeeper role for vaccines that goes well beyond the scope of FDA approval. Vaccines approved by the FDA but not appearing on the CDC routine vaccination schedule are likely to gain little traction because of a lack of guidance to providers on how to use the vaccine -- and lack of payer coverage.
In other words, minus a positive ACIP recommendation, a disease that is responsible for approximately 200,000 emergency room visits a year will continue to harass patients and haunt our healthcare system. Minus a positive ACIP vote, new and potentially life-saving vaccines are redlined and another nail is hammered into the coffin of innovation.
The FDA recognized the importance of the adult indication for Prevnar 13 (currently the only vaccine for pneumococcal bacteria approved in the United States for adults 50 years of age or older is Pneumovax which is only effective against invasive pneumonia and not effective on the more common, pneumococcal pneumonia. Prevnar 13 is a conjugate which means it contains a pneumococcal bacteria bound to a protein to help the body’s immune system recognize the bacteria and will have a longer lasting immune response), but at the upcoming ACIP meeting (February 22-23), there is only a discussion of 13-valent pneumococcal conjugate vaccine. Just discussion. That’s important – but a positive recommendation is crucial. Otherwise it is, in many unfortunate respects, just talk.
The need for this patient population exists. The vaccine is safe and effective. Without a recommendation the vaccine will not be available to a large swath of Americans. It’s time for ACIP to call the question.
The battle against the “dangerous idiots” of vaccine denial is dangerous enough, we must avoid the equally daunting danger of … inertia.
As the saying goes, “Truth fears no questions.”
Hence, Ken Abramowitz, our guest blogger reminds us of the pitfalls (and pluses) of Obamacare. Ken is a co-founder and Managing General Partner of NGN Capital. He joined NGN Capital from The Carlyle Group in New York where he was Managing Director from 2001 to 2003, focused on U.S. buyout opportunities in the healthcare industry. Beginning July 2003, he transitioned to Senior Advisor at Carlyle in order to devote the time necessary to create a dedicated healthcare fund on behalf of Carlyle. Prior to joining Carlyle, Mr. Abramowitz worked as an Analyst at Sanford C. Bernstein & Co. where he covered the medical-supply, hospital-management and HMO industries for 23 years, after which he was an EGS Securities Healthcare Fund Manager.
We look forward to his future posts on health care reform and medical innovation.
ObamaCare imposes European socialism “lite” on the U.S. The plan involves 2,800 pages of legislation and, soon, 10,000-15,000 pages of regulation. It is a massively underfunded $900 billion program that relies on stealing $500 billion from a grossly underfunded Medicare program and it does not recognize the $200 billion cost of offsetting the 21% Medicare physician cut.
Rather than making medicine more affordable, It will bend the cost curve upward by taxing insurance carriers, medical device companies, and pharmaceutical companies. It also raises costs in the individual market by imposing insurance mandates (guaranteed issue, narrow underwriting bands, no lifetime benefit limits).
Worse it sets up grossly underfunded individual insurance exchanges that will quickly exceed projected spending. therefore they eventually seek to control cost under dysfunctional price controls. Thereafter insurance carriers will exit the market, tempting the government to take over as it did after the collapse of the housing market. These exchanges offer a costly defined benefit that is 65% subsidized by Federal and State governments, but should have been financed by a more affordable defined contribution.
On the positive side, the bill does provide genuine subsidies to finance and facilitate the “meaningful” use of EMRs and IT integration. On the really positive side, the massive government overreach we will see voters continue to reject Obamacare as they did in 2010. Hence, while the plan is guaranteed to blow up by 2015 fortunately 50% of the bill will be repealed before then. Though no one knows which 50%.
Didn't we hear that in the 1970s when people like Emanuel were predicting insurance companies would become obsolete and be replaced by HMOs that would manage health and improve outcomes?
The faith in administrative changes or addition of regulation to improve, shape, control human behavior is particularly strong among health care policy experts of all stripes. I believe that it is technological progress that makes certain types of care -- fee driven, intermediate or palliative treatments produced through hardware or in hospitals -- obsolete. Think of how infectious diseases were generally treated less than 50 years ago, the use of medicines instead of institutions for people with mental illness, same day surgery vs. the 5 day stay.
ACOs were designed to be conduits for government produced guidelines that are biased against new technology. They are organized against innovation, not to capitalize on it.
As a result, I believe by 2020 not only will the current form of underwriting be obsolete -- because of advances in personalized medicine and direct to consumer delivery of healthcare -- but so will ACO's and Obamacare. If you think it was surprisingly easy to overthrow Arab dictators wait till you and I know more about our health sooner than government bureaucrats who produce outdated guidelines and mandates.
Here's a link to Zeke's article:
http://opinionator.blogs.nytimes.com/2012/01/30/the-end-of-health-insurance-companies/?nl=opinion&emc=tya1
It's true that the cost of sequencing continues to follow Moore's law -- exponential decline in material and equipment costs and increased computing power -- so that what Illumina does with supercomputers is something that doctors and patients will be able to do with smartphones. But Roche is not interesting in the hardware of sequencing. If it did, it could just buy a bunch of machines for a lot less that $5.7 billion.
In fact, Roche knows that sequencing will become commonplace. I think it wants Illumina because of it's partnerships with clinical labs worldwide to perform sequencing. Distribution for Roche diagnostics and products -- as the firm focuses on targeted therapy -- is more valuable than equipment or sequencing. Roche also sells glucose kits too and find that marketplace pretty lucractive.
Should Illumina sell? I don't know and have no opinion. However, I remember when Yahoo snubbed a Microsoft acquisition for a hefty premium over it's share price. Now Yahoo is scrambling to find a buy at a share price far below that offer. Information is quickly becoming a commodity in health care. In 10 years drug companies will be delivering individual content directly to consumers to treat illness. Perhaps Roche believes it can be a source of revenue growth. In any event, acquiring Illumina is about how medical care will be organized in the future, not about it's microarrays now.
Update on the Office of the Center Director and Office of Drug Evaluation1
CDER Staff:
I want to update you on recent changes in my Immediate Office to further enhance medical and scientific decision-making across CDER. These changes also affect the Office of Drug Evaluation 1 (ODE1), Office of New Drugs.
I have asked Robert (Bob) Temple, M.D., to give up his role as the Acting Director of ODE1, so that he can devote more of his time and vast expertise to his other role as the Deputy Center Director for Clinical Science. Ellis Unger, M.D., currently the Deputy Director of ODE1, will serve as Acting Director of ODE1. Bob will continue as Acting Deputy Director of ODEI and plans to maintain substantial (but somewhat less) involvement in ODEI activities.
In November 2009, due to the growth of the Center’s responsibilities, I appointed Bob as the Deputy Center Director for Clinical Science with primary responsibility for high level initiatives and programs related to clinical science and clinical trial methodology issues. At that time, Bob agreed to wear two hats and continue as Acting Director of ODE1.
As Deputy Center Director for Clinical Science, Bob has played and continues to play a major role in directing and executing many cross-cutting CDER functions, which enhance the quality and consistency of our operations. Now he will have more time to further provide valuable regulatory input and methodological assistance across the Center.
I am grateful to Bob for serving ODE1 with excellence and superb leadership. I also am grateful that we have someone like Ellis to step in and assume the Office Director position on an Acting basis. Ellis has been with CDER since 2004, serving in various leadership roles, and in the ODE1 Deputy Director capacity since August 2008. I am confident that he will continue to serve ODE1 exceptionally well.
Janet Woodcock
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
