Twitter Updates

    follow me on Twitter

    My Profile

    • EXPERTISE -
      Authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; issues and crisis management. Frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!

    About This Blog

    • Eye on FDA is published by Mark Senak of Fleishman-Hillard's Washington, D.C. office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of Fleishman-Hillard or its clients.

    My Favorite Dogs

    • January20063_005
      Nick and Nora

    Other Fleishman-Hillard Bloggers

    Stats

    • eXTReMe Tracker

    Eye on FDA edrugsearch blog ranking

    • Healthcare 100

    « India Grants Patent to AIDS Drug | Main | Chalk Up Yet Another Multiple Approvable Letter - This Time for Neurocrine »

    December 12, 2007

    Barack Obama - Where the Candidates Stand - Part 9

    Barackobama

    1. Barack to the Future!  That was a campaign slogan I thought of quite some time ago, I can't imagine why the campaign hasn't recruited me! 
    2. The Obama plan addresses the needs for greater insurance coverage among Americans, but he also goes into detail about how he would get there. One area he addresses on his Senate site is the fact that he has supported genomics research.  "Genomics is the study of how a person's genetic makeup affects propensity for disease and response to treatment. Research in this area has the potential to predict which people will get sick, diagnose illnesses earlier, and screen patients to determine which drugs will be safe and effective. In August 2006, Senator Obama introduced the Genomics and Personalized Medicine Act, which would increase funding for research on genomics, expand the genomics workforce, provide a tax credit for the development of diagnostic tests that can improve the safety or effectiveness of drugs, and reaffirm the need to protect genetic privacy.:

    Respecting our five domains:

    1. Importation of Drugs - On the one hand, this candidate recognizes that it is important that drug companies receive a profit from their investment in cures.  But there is a takeaway as well.  "Pharmaceutical companies should profit when their research and development results in a groundbreaking new drug. But some companies are exploiting Americans by dramatically overcharging U.S. consumers. These companies are selling the exact same drugs in Europe and Canada but charging Americans a 67 percent premium. Obama will allow Americans to buy their medicines from other developed countries if the drugs are safe and prices are lower outside the U.S."
    2. Medicare Part D Reform - The Senator favors reforming Part D to allow the government to negotiate prices with the pharmaceutical industry.  According to his campaign site, "[t]he 2003 Medicare Prescription Drug Improvement and Modernization Act bans the government from negotiating down the prices of prescription drugs, even though the Department of Veterans Affairs’ negotiation of prescription drug prices with pharmaceutical companies has garnered significant savings for taxpayers. Obama will repeal the ban on direct negotiation with drug companies and use the resulting savings, which could be as high as $30 billion,50 to further invest in improving health care coverage and quality.
    3. Pharmaceutical Marketing Restrictions - Nothing found. 
    4. Follow-on-Biologic Regulation - Nothing found, however, there is a strong theme related to introducing generics into the mix to control costs, see below.
    5. Generic Promotion - Obama directly addresses this in his plan, which few others do so directly.  "Some drug manufacturers are explicitly paying generic drug makers not to enter the market so they can preserve their monopolies and keep charging Americans exorbitant prices for brand name products. The Obama plan will work to ensure that market power does not lead to higher prices for consumers. His plan will work to increase use of generic drugs in the new public plan, Medicare, Medicaid, FEHBP and prohibit large drug companies from keeping generics out of markets.

    Analysis:  More than any other candidate, his site addresses each of the domains with particularity.  While the candidate gives a nod to the need for profits for drug companies for future research, when it comes to the fact that Americans are charged more for products than other countries on his importation policy, it does not take into account a global pricing structure that at this point, requires that more developed nations subsidize access for lesser developed countries.  That is an essential component for any commentary on drug pricing in America. 

    NOTE:  After publishing this post, I modified it later the same day to remove an accidental reference to another Senator - the result of late night cutting and pasting! 

    TrackBack

    TrackBack URL for this entry:
    http://www.typepad.com/t/trackback/721595/24060092

    Listed below are links to weblogs that reference Barack Obama - Where the Candidates Stand - Part 9:

    Comments

    Post a comment

    If you have a TypeKey or TypePad account, please Sign In

    Subscribe / Email Me

    Enter your email address:

    Delivered by FeedBurner

    Search

    • Google

      WWW
      eyeonfda.com

    December 2008

    Sun Mon Tue Wed Thu Fri Sat
      1 2 3 4 5 6
    7 8 9 10 11 12 13
    14 15 16 17 18 19 20
    21 22 23 24 25 26 27
    28 29 30 31