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Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Obama

White House Weekly Address: The Pitch for Health Reform

With the critical Senate Finance bill still pending, here’s the pitch from the White House:

The only two things I heard Obama describe as requirements for a bill he would sign:

  • No addition to the deficit over 10 years; and
  • Insurance exchange: one-stop shop to compare prices, coverage and, interestingly, track record.

He definitely advocated a public plan option, but it wasn’t clear whether that was inside or outside the list of requirements.

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Trends Update — Biosimilars: Sen. Kennedy, Gov. Dean and NVCA Study all Support 12+ Years of Exclusivity

The debate over the proper data exclusivity period for innovator biologics (as protection against biosimilars/follow-on biologics/subsequent-entry biologics) had a busy week last week.

A couple of thoughts:

  1. The exclusivity period in the EU is 8 years (data) +2 years (marketing) +1 year (for new indications), and the current proposal in Canada is 6 years, so a baseline of 12-14 years’ protection would leave the U.S. system paying for exclusive pricing longer than other major markets.  I’m fine if the U.S. decides to further subsidize pharma innovation, but I’d prefer a more transparent approach with less market distortion; and
  2. It’s hard to balance rationally between data exclusivity and patent exclusivity when the patent system is in significant flux.  Having patent reform as a moving piece (or as part of biosimilars legislation) only muddies the debate.

Update: The WSJ picks these up this morning too.  Here’s the NVCA story, and here’s the one on Kennedy’s efforts and the debate it’s generating in committee.

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Francis Collins Nominated to be NIH’s Next Director

NIH LogoOver to you, White House press release:

“President Obama said, ‘The National Institutes of Health stands as a model when it comes to science and research. My administration is committed to promoting scientific integrity and pioneering scientific research and I am confident that Dr. Francis Collins will lead the NIH to achieve these goals. Dr. Collins is one of the top scientists in the world, and his groundbreaking work has changed the very ways we consider our health and examine disease. I look forward to working with him in the months and years ahead.'”

Bonus: See this very well-timed (if not very optimistic) piece in Nature News today on the 20th anniversary of the discovery of the CF gene (by Collins and Lap-Chee Tsui, the latter then at Sick Kids in Toronto).

Bonus #2 — Three Degrees of Francis Collins: I did my Ph.D. in Doug Bishop’s lab. Doug did his post-doc in Nancy Kleckner’s lab. Nancy and Francis Collins were elected to the National Academy of Sciences together in 1993. Ta da! Your turn…

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Obama Budget 2010: HHS Highlights

The Obama Administration delivered its FY2010 Budget to Congress yesterday. Among the highlights of the Department of Health and Human Services Budget:

  • $511,000,000 increase to FDA’s budget with $259 million for food safety inspections, surveillance etc.
  • $584,000,000 for influenza preparedness, including purchase and development of vaccines, antivirals, diagnostics and supplies
  • $275,000,000 for advanced development of biodefense countermeasures (antivirals, vaccines, diagnostics)
  • $30,000,000,000 for NIH which is flat over last year, but remember NIH recieved $10bn in the American Recovery and Reinvestment Act
  • $44,000,000 for Office of National Coordinator for Health IT.  The budget projects a $432,000,000 spend in Recovery Act Health IT activities in 2009 and an $809,000,000 spend in 2010 (National Coordinator Office received $2bn in Recovery Act mostly for competitive grants for healthcare providers to incorporate health IT).

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Senator Grassley Update: No to Judiciary, Yes to Lunch

Sen. Charles Grassley will not be moving to replace Sen. Specter on the Judiciary committee, contrary to the speculation that I previously passed along.  He did have lunch with Sen. Baucus, the President and the Vice President today where the topic was apparently staying off airplanes health reform.

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Trends Update — Electronic Medical Records: Military and Vetrans System Should Speed Adoption, Standards

In a speech Thursday, President Obama announced that the Defense and Veterans Affairs departments will set up a system that will ultimately provide “unified lifetime electronic health record” for members of the armed services. 

Any large-scale government implementation like this is bound to help set standards and encourage adoption by other providers.  With luck it will also, over time, provide data on cost-savings and care improvements.

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SOX-Like Controls for Scientific Integrity

Yesterday, President Obama called for a restoration of scientific integrity to government decision-making in a sweeping Presidential Memorandum.  Specifically, he directed the Office of Science and Technology Policy (OSTP) to develop recommendations “designed to guarantee scientific integrity throughout the executive branch.”

Well, I have a recommendation: OSTP should use the Sarbanes-Oxley Act (SOX) as a model to create a set of internal controls and disclosure controls for assessment and reporting of the use of scientific information by government agencies.

Why?  Three reasons:

  1. The principles in the Presidential Memorandum indicate several parallels to SOX and general corporate governance requirements, as set out in the chart below
  2. Scientific information is critical as an input to govenrment decision making just as much as financial information is critical to corporate decision making, and should be treated that way, and
  3. OSTP could leverage existing governance expertise, which is key, because they only have 120 days from yesterday to develop the recommendations.

Concept

Presidential Memorandum

Sarbanes-Oxley / Governance

Oversight

The Director of OSTP is responsible for “ensuring the highest level of integrity in all aspects of the executive branch’s involvement with scientific and technological processes.”

The PCAOB was created to protect investors and the public interest by promoting informative, fair, and independent audit reports.

Competence

The selection and retention of candidates for science and technology positions in the executive branch should be based on the candidate’s knowledge, credentials, experience, and integrity;

Not strictly part of SOX, but governance rules include the requirement for a financial expert on the audit committee.

Integrity/ Independence

Each agency should have appropriate rules and procedures to ensure the integrity of the scientific process within the agency;

Title II of SOX establishes standards for external auditor independence, to limit conflicts of interest.

Accuracy

When scientific or technological information is considered in policy decisions, the information should be subject to well-established scientific processes, including peer review where appropriate, and each agency should appropriately and accurately reflect that information in complying with and applying relevant statutory standards;

Title III of SOX requires that senior executives certify the accuracy and completeness of corporate financial reports.  Civil and criminal liability attaches to certifications by the CEO and CFO that the company’s public filings “fairly present in all material respects” the relevant financial information.

Disclosure

Except for information that is properly restricted from disclosure under procedures established in accordance with statute, regulation, Executive Order, or Presidential Memorandum, each agency should make available to the public the scientific or technological findings or conclusions considered or relied on in policy decisions;

This is not new with SOX.  Public disclosure has been the cornerstone of securities laws since the 1930s.

Monitor procedures

Each agency should have in place procedures to identify and address instances in which the scientific process or the integrity of scientific and technological information may be compromised; and

SOX requires certification of internal controls to ensure that any “significant deficiencies” and “material weaknesses” are addressed;  and certification of disclosure controls to ensure that “material information … is made known to management.”

Protect whistleblowers

Each agency should adopt such additional procedures, including any appropriate whistleblower protections, as are necessary to ensure the integrity of scientific and technological information and processes on which the agency relies in its decisionmaking or otherwise uses or prepares.

SOX Section 1107 contains whistleblower protections, including criminal penalties for violations.

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Restoring Scientific Integrity to Government Decision Making

In addition to Obama’s announcement today lifting the ban on federal funding of stem cell reasearch, he also issued a presidential memorandum

To ensure that in this new Administration, we base our public policies on the soundest science; that we appoint scientific advisors based on their credentials and experience, not their politics or ideology; and that we are open and honest with the American people about the science behind our decisions.

To which I can only say: thank goodness. 

Read the full memorandum after the jump…

Canadian Budget Reaction Boils Over

A meeting this week between the Canadian Association of University Teachers and Gary Goodyear, Canada’s Minister of Science and Technology descended into a shouting match over cuts to research funding announced in Canada’s 2009 federal budget.

Interestingly, the Minister focused on a point I made last week — that the Canadian approach lately has centered on commercialization:

Mr. Goodyear, a chiropractor from Cambridge, Ont., said the government has been steadily investing in science and technology since 2006, with a new emphasis on commercialization…

I think commercialization is a worthwhile investment; but funding commercialization at the expense of Canadian research is a major  blunder, for the following reasons:

  1. There is no commercialization without research.  Researchers from Boston or San Francisco or Edinburgh will not suddenly move here to start their companies because of extra NRC-IRAP funding.  If the developments aren’t made here, the companies won’t be formed here either.
  2. Research is an area in which Canada punches above its weight.  Check out our Friday Science Reviews and you will see international headlines and top tier journal articles.  However, a lot of hard reputational work is undone by the kind of international reaction generated by the 2009 budget.
  3. The timing is bad.  The increased research funding provided by the U.S. budget and stimulus makes for a terrible comparison.  Plus, Obama is poised to lift the U.S. federal funding ban on stem cell research tomorrow (Monday); and this is an area where we have benefited from an extra structural advantage that is about to be erased (as observers in the UK have already noted).

So, Mr. Goodyear, by all means focus on commercialization.  We can (and will) quibble about that implementation another time.  But in the meantime, restore the research funding that makes us a world-class producer of scientific innovation.

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Obama, Sebelius and Drug Importation

The President’s Budget released last week highlighted President Obama’s support for importing cheaper drugs from Canada (pdf).  The Washington Post writes that Governor and HHS Secretary-elect Kathleen Sebelius was successful in having Kansas join a multistate consortium that allowed Kansans to order prescription drugs from Canada, Britain and Ireland, often at a lower price than in the United States. As a result of Obama’s proposal, drug companies took a hit on the markets last week.

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GTC Biotherapeutics goes for a Regulatory Double Combo Shot

GTC Biotherapeutics, which recently saw ATryn approved, announced a collaboration agreement with AgResearch Limited, a New Zealand Crown Research Institute. 

AgResearch will develop genetically modified animals capable of producing the building blocks for “biosimilar” versions of existing products that will begin coming off U.S. patent in 2014.

The double combo shot:  the success of the collaboration depends on

  1. a continuing trend of GE animal approvals, as well as
  2. the successful introduction of a biosimilars pathway in the U.S., (which is called for in Obama’s budget).

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Rep. Waxman, Reigel v Medtronic and Wyeth v Levine

Last Summer, the U.S. Supreme Court held in Reigel v. Medtronic that the premarket approval (PMA) process for medical devices pre-empts liability under State common law for claims challenging the safety or effectiveness of medical devices.  Wyeth v. Levine, which the U.S. Supreme Court heard last Fall, but has not decided, makes a parallel argument with respect to labelling of FDA-approved drugs. Together, these two cases could reshape liability for products under the FDA’s purview in a way that looks very much like tort reform, and therefore, have seemed ripe for a legislative response.  A story in yesterday’s Minneapolis-St.Paul Star Tribune includes a statement from Rep. Henry Waxman, D- Calif. that

Waxman and Rep. Frank Pallone Jr., D-N.J., plan to introduce legislation that would circumvent the Supreme Court ruling and “protect Americans from dangerous medical devices.”

and notes that Barack Obama was one of the cosponsors of the Senate bill introduced last year to address the issue. more analysis after the jump…

Trends in 2009: Comparative Effectiveness and Personalized Medicine

Two potentially conflicting trends may see a dramatically increased profile in 2009: Government Bailouts and Free-Market Capitalism Comparative Effectiveness and Personalized Medicine. Both have been highlighted by the incoming Obama administration.  Details and analysis after the jump…

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