Tuesday, July 14, 2009


See Last Two Threads.....

To clarify, the bill to extent biologic exclusivity only passed in the Senate's HELP Committee. It has not yet been endorsed by the full Senate nor the House. See below...This puppy definitely is not yet a dog.....

I predict some sort of eventual compromise. Eight years? Whoever guesses correctly wins a free subscription to Phamalittle....


US Senate panel backs 12-year biotech drug shelter
Mon Jul 13, 2009 11:57pm EDT

* Decision seen as victory for biotech drugmakers* White House, AARP back seven-year limit* Generic drugmakers decry decision as blow to consumers (Adds biotech industry group comment, paragraphs 10-11)By Lisa RichwineWASHINGTON, July 13 (Reuters) -

Biotechnology medicines would be protected from cheaper rivals for 12 years under a plan that cleared a U.S. Senate committee on Monday.The 16-7 vote in the Senate health committee was a victory for major biotech drugmakers such as Amgen Inc (AMGN.O) and Roche Holding AG (ROG.VX). Manufacturers of brand-name biotech drugs have been pushing for a period of 12 to 14 years before generic copies of their medicines can win approval.

Generic drugmakers have backed proposals limiting the exclusivity period to five or seven years.The Senate plan could change when the healthcare bill goes to the floor for a vote. Senators also will need to work out an agreement with the House, where the issue is still being debated.A key lawmaker, House Energy and Commerce Committee Chairman Henry Waxman, backs up to five years of protection.Biotech medicines, or biologics, are made from living things and are more complicated to produce than traditional, chemical-based drugs. They can cost tens of thousands of dollars per year.The drugs treat conditions ranging from anemia and rheumatoid arthritis to cancer. Examples include Roche's Herceptin and Avastin cancer treatments, and Amgen's Epogen and Aranesp anemia therapies.Lawmakers working on an overhaul of the U.S. healthcare system are crafting plans to create a legal path for approval of cheaper copies of biotech medicines. The exclusivity period for the brand-name versions has been a key sticking point.Brand-name companies say they need an adequate period without competition to encourage companies to develop new medicines."A minimum of 12 years of data exclusivity establishes a fair and reasonable period to ensure continued biomedical innovation and provide the benefits of competition," said Jim Greenwood, president of the Biotechnology Industry Organization, which represents brand-name biotech drugmakers.The Senate panel's vote "marks a significant defeat for those who would shortchange future breakthroughs and the hope for cures for some of the most devastating diseases by providing an abbreviated period of data exclusivity," Greenwood said.The committee rejected a shorter period of seven years, the time the White House says strikes an appropriate balance between promoting innovation and providing competition. Seniors lobbying group AARP also backed seven years."This unprecedented action strikes a huge blow to consumers at a time when many Americans are struggling to pay for the medicines they need," Kathleen Jaeger, president of the Generic Pharmaceutical Association, said of the Senate panel's action.Companies aiming to sell copies of biologics include generic drugmakers such as Teva Pharmaceutical Industries Ltd (TEVA.TA) and Mylan Inc (MYL.O). (Editing by Eric Walsh)


  1. It is time for everyone to write their senators, congressman and the president on this issue specifically.

    The current patent protection for prescription drugs is 17 years, every decade or so the pharmaceutical industry bands together to have the period extended.

    The problem with biologics is that we are finding that more and more diseases will be treated with biologics. Extending the patent period for biologics at this time will make the treatments cost prohibitive for many patients.

    For example there is a new monoclonal antibody on the market that cost up to 600K per patient per year. It doesn't cure, but extends lives. Can you imagine if that antibody was protected for a full twelve years? Who would pay? Why bother with treatments at all if the majority of the patients who need access to them cannot be treated?

    The poor, uninsured will either be completely blocked from these treatments or the government will most certainly step in and cover the costs, as this would be the responsible ethical thing to do.

    We are pricing ourselves out of business. There has got to be a more economical way to bring these innovations to market.

    Maybe it is time for another petition....

  2. I agree, Former. Now would be a good time for those who dislike the biologics bill to tell Congress they are against legislation that would keep “…patients [from] quicker access to cheaper versions of costly medicines used to treat ailments including cancer, Parkinson's, diabetes and rheumatoid arthritis.” See: http://www.newsday.com/news/politics/wire/sns-ap-us-congress-biotech-drugs,0,1202030.story

    Contacting President Obama and Congress: (Copy and paste following links into Google)

    Contact Us (President Obama)

    Write Your Representative - Contact your Congressperson in the U.S. House of Representatives.

    U.S. Senate: Senators Home

  3. What a crazy world. I wish there was a way to comprehend all that pharma has done and is trying to do to insure taking larger and larger portions of our expendable dollars.

    Does anyone know if there is a graphic representation of the pharma process - from product idea to marketing to product consumption to post marketing monitoring and everything else in between? If there is I would like to see where each step has been or is being modified, controlled, bypassed or ignored by pharma.

    I’ve seen simplified caricature-like graphics for other processes that make it easier to comprehend a complicated system. Would this be possible for the world of pharma? Maybe a medical student project Justice? Just a thought.

    I propose that the level of power (directly proportional to the amount of money) that pharma has garnered has made the system begin to run out of control in favor of the pharmaceutical industry. They are consuming all regulators. When that is finished what will the result be?

  4. I have this specific question: Why is there so much disparity _now_ between biologic patent protection and drugs? As far as I know, the post-approval patent life for most drugs is about 8 years (on the market). Are folks sure that the numbers we're hearing about biologics are not post-approval??

    There are plenty of graphics in pharm. textbooks about the "process"==from discovery, through the various stages of testing, preparation for an NDA, FDA process, etc. Promotional/marketing dimensions are rarely, if ever, included--at least in what I have seen.


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