Posts Tagged ‘FDA’

By: The Advanced Medical Technology Association (“AdvaMed”), prepared by Josh Makower, M.D., consulting Professor of Medicine, Stanford University and Founder, President & Chief Executive Officer of ExploraMed Development. Article reposted from The Coelyn Group.

OneMedPlace recently reported that “Growth in the life sciences industries will greatly depend on how the FDA responds to growing complaints that they are stifling medical technologies.  Companies have seen a vast difference in the approval processes in Europe vs. the U.S.  A study released by Stanford University indicated that the cost of bringing a technology to market is dramatically lower in Europe.”

The Advanced Medical Technology Association (“AdvaMed”) recently released the report, prepared by Josh Makower, M.D., consulting Professor of Medicine, Stanford University and Founder, President & Chief Executive Officer of ExploraMed Development, LLC; et al, “FDA Impact on U.S. Medical Technology Innovation,” which garnered responses from more than 200 companies concerning their experiences in working with the FDA.  Participants were also asked about their experiences working with European regulatory authorities in order to offer a comparison between aspects of the two dominant regulatory systems.

“In general, survey respondents viewed current U.S. regulatory processes for making products available to patients as unpredictable and characterized by disruptions and delays,” the results summary states.  Forty-four percent (44%) indicated that part way through the premarket regulatory process they experienced untimely changes in key personnel, including the lead reviewer and/or branch chief responsible for the product’s evaluation.  Thirty-four percent (34%) of respondents also reported that appropriate FDA staff and/or physician advisors to the FDA were not present at key meetings between the FDA and the company.”

The report goes on to highlight that those factors contribute to significant delays in navigating FDA regulatory processes, with premarket process for 510(k) pathway devices (of low-to moderate risk) taking an average of 10 months from first filing to clearance.  Devices requiring a clinical study for low- to moderate-risk devices before making a regulatory submission, the premarket process took an average of 31 months from first communication to being cleared to market while, in comparison, it took an average of 7 months in Europe.

For higher risk devices seeking premarket approvals, responding companies indicated that it took an average of 54 months to work with the FDA from first communication to being approved to market the device.  In Europe, it took an average of 11 months.”

Beyond the time gap comparing FDA and Europe approval processes, the survey also showed that the average total cost for a low- to moderate-risk 510(k) product from concept to clearance was approximately $31 million, with $24 million spent on FDA dependent and/or related activities.  For a higher-risk PMA product, the average total cost from concept to approval was approximately $94 million, with $75 million spent on stages linked to the FDA.

According to the report, these statistics result in a “significant, measurable cost to U.S. patients in the form of a device lag.  Respondents reported that their devices were available to U.S. citizens, on average, nearly 2 full years later than patients in other countries, due to delays with the FDA and/or company decisions to pursue markets outside the U.S. before initiating time-consuming, expensive regulatory processes in their own country.”

Stephen J. Ubl, President & Chief Executive Officer of AdvaMed, says, “This report is a wake-up call for those who want to promote medical innovation and preserve American jobs.  A regulatory environment that is marked by needless delays and inefficiencies makes it harder for medical innovation to thrive and companies to survive.  These delays particularly hurt small companies and their ability to produce next generation technologies.”

To read the full report go to: http://www.advamed.org/NR/rdonlyres/040E6C33-380B-4F6B-AB58-9AB1C0A7A3CF/0/makowerreportfinal.pdf

Ultimately, growth within the life sciences will continue at a quick pace during the next few years, with development of R&D pipelines, alliances, and partnerships being a key factor for success.

As the economy continues to chug back to full force, the only obstacle appears to be the differing of opinions between the medical device manufacturers and the FDA.  Perhaps if they come to a meeting of the minds, these growth projections will not just be projections, but will be the reality of a growing field that is quickly, and effectively, delivering what the U.S. healthcare system requires.”

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What the industry needs is not a bailout, but some sensible policies

By Stephanie Marrus

Biotech is in trouble, again.

125 of the 370 US-based public companies have less than six months of cash — a 90% increase in close-to-broke companies compared to 2007, according to the Biotechnology Industry Organization (BIO). And that number does not take into account the private companies suffering; about 40% of small private biotechs have less than one year of cash.

Venture capitalists are hoarding cash or closing their doors; private equity firms are retrenching, the public markets are in tatters. Big Pharma is shopping with a discriminating eye; the companies that most need to be saved are the least likely to be bought. The industry expects many bankruptcy filings, clinical trial cancellations, layoffs and sell outs.

The JP Morgan Healthcare Conference, arguably the premiere healthcare investment conference in the world took place in San Francisco last month. There is no better venue to dial into industry sentiment. Big Pharma, biotech CEOs, executive search consultants, attorneys, accountants, Wall Street analysts, institutional investors, investment banks, venture capitalists, hedge funds were all there. The conference buzz was: “No buzz.” “Cautiously pessimistic.” “Wait two years and come up for air.” “The well is dry.”

Drug development has always been a tough game. Most companies live in a hand-to-mouth existence, hoping that their science progresses far enough with successful results to look appetizing to funding and sources. It takes 10-15 years before you know if you have a drug that passes human clinical testing, hundreds of millions of dollars in development cost.

Companies with hot technologies or exciting drug candidates get funded either by venture capital, pharmaceutical partnerships, acquisition or the public markets. In past downturns, a small number of biotechs have merged or disappeared but most managed to survive. 2009 is different.

Some will argue we are due a bailout. Surely the biotech industry is as deserving as the automobile industry. We discover and develop medicines that can save human life, a higher calling that should entitle us to at least as much help as the makers of gas-guzzling autos. There is no question that the cost of discovering and developing a pharmaceutical is off the charts and the failure rate is astronomical.

On the other hand, there are too many biotech companies with non-viable businesses. It is a widely held opinion that many companies are “science projects” rather than real businesses. Companies with complimentary technologies or programs could benefit by pooling resources rather than maintaining their own duplicative infrastructures. Management teams have a vested interest in keeping their company intact to the detriment of their shareholders. Is it finally going to be the time to rationalize the industry?

Some companies should continue life only as part of a merged entity. Some companies should sell their assets. Other companies may have to bite the bullet and shut their doors. Management needs to act responsibly for the shareholders even if it means their jobs will end.

For the many firms that have created real value, there should be a future even in these economic times. For that to happen, though, government policy needs to facilitate the continuation of these firms, not obstruct it. Here are a few key policy changes that would help.

FDA: Appoint a respected leader for the FDA and resource the agency properly. Do not go overboard with control in the post-Vioxx era, thereby preventing life saving drugs from coming to market. Let informed patients choose — sick people without good options are willing to take some risk.

Price controls: Do not make the mistake of interfering with free market pricing mechanisms. If a drug is overpriced relative to its efficacy, it will not sell. Setting a ceiling or instituting other price controls will only serve to insure that new drugs are not developed. Industry must see an economic return to invest in highly risky drug development or it will opt out.

Intellectual property: Intellectual property protection is the lifeblood of the industry, and the reason investors will fund companies without revenue. Set policies to enhance and extend protection, not dilute it. Do not weaken the predictability, value and enforceability of patents such as provisions of the Patent Reform Act of 2007, which made it through the House but thankfully stalled in the Senate last year.

Funding sources: Increase NIH funding so that fledgling companies have a pre-venture capital source of funds. NIH funding has remained stagnant for a number of years as costs continue to rise. Consider the national venture capital fund model used in other countries to provide financing during the “Valley of Death,” the period when companies are engaged in translational research to bridge academe to industry and not yet fundable by venture capital.

It is in the public interest to help the beleaguered biotech industry. Biotech companies have discovered hundreds of therapies, vaccines and diagnostics that impact human life. Biotech is increasingly serving as a productive engine for new drug development, replacing big pharmaceutical companies as innovation leader. We have accomplished much with scarce resources and deserve to survive and prosper.

Stephanie Marrus is a life sciences management consultant/ interim executive based in the Bay Area who advises firms on strategy, business development, communications, operations, restructurings and M&A. She can be reached at portfoliostrategies@gmail.com.

Read more here.

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