{"id":639,"date":"2010-03-23T23:41:06","date_gmt":"2010-03-24T07:41:06","guid":{"rendered":"http:\/\/www.spreadingscience.com\/2010\/03\/23\/my-oped-in-xconomy\/"},"modified":"2010-03-23T23:41:06","modified_gmt":"2010-03-24T07:41:06","slug":"my-oped-in-xconomy","status":"publish","type":"post","link":"https:\/\/www.spreadingscience.com\/2010\/03\/23\/my-oped-in-xconomy\/","title":{"rendered":"My Op\/Ed in Xconomy"},"content":{"rendered":"

\n\"petri by kaibara87<\/b><\/i><\/a><\/span><\/p>\n

The opinion piece I wrote for Xconomy<\/a> has been published. Luke Timmerman<\/a> asked me on Monday to examine the bill and the sections that impacted the Biotechnology industry. I had not even realized there were parts of the huge healthcare reform bill.<\/i><\/p>\n

I started writing on Monday evening and got Luke my version by about 1 PM on Tuesday (I had to take my car to the shop for its 15,000 checkup or I would have been done sooner). Luke had some edits and it was ready by early evening.<\/em><\/p>\n

Everything was done using online technologies. Even 5 years ago it would have been hard to put this all together in such a short time. I essentially started from zero on the specifics (I mean how many people have actually read any of the healthcare reform bill itself?), educated myself rapidly, used my background of 25 years in the industry to form an opinion and composed the piece. I then carried on a ‘conversation’ with Luke to get it into final shape.<\/i><\/p>\n

I found the relevant parts using Open Congress’s interface<\/a>, which allows you to link to specific paragraphs, as well as leave comments. It presents a unique way for citizens to interact with the legislation that our Congress is working on. Not only are there links to every piece of information one may want, there are also links to news stories, and other facts (Like the Senate version has over 400,000 words.)<\/i><\/p>\n

Without this web site, it would have been very difficult to even find the sections dealing with biotechnology, much less try to understand them, It was very easy to search for the relevant sections and get an understanding of what they really said. I read a few articles online to get some other viewpoints and then wrote my opinion of the sections.<\/i><\/p>\n

The fact that the biotechnology industry now gets 12 years of market exclusivity for its products, several years longer than for the small molecule drugs sold by pharmaceutical companies, is really a pretty big deal.<\/em><\/p>\n

There has been uncertainty for several years over this time frame, with the FTC feeling there should be little or no market exclusivity outside of the patent time frame to the industry’s organization, BIO, which wanted at least 12 years without regard of patent considerations.<\/i><\/p>\n

Not knowing just how long a time period a new biologic might be free of competition can have a large effect on determining which therapeutics make it to the market place. Now those who model the value of a product have much surer time frames to work with.<\/i><\/p>\n

I do not think the bill is as friendly to those companies hoping to create ‘generic’ biologics called biosimilars. While it does delineate a path to government approval, the legislation does not make it easy. There are some substantial costs for getting approval of these products. They may not be very much cheaper than the original therapeutic itself. and they do not get any real exclusivity for their products in the end.<\/i><\/p>\n

For many possible follow-on biologics it will simply be too expensive to take them to market. The large costs incurred while doing this will also make it harder for them to take market share away from a biologic, which has had 12 years of unfettered ability to market itself and its positive results to the customers. at least market share based on cost.<\/i><\/p>\n

And, as I read the section dealing with patent issues, I became even more aware of the hard road for these follow-on generics. In order to get patent issues dealt with before the follow-on biologic is marketed, the patent holders\/licensees of the original drug must be furnished the same information that is submitted in the application to the FDA – the results of clinical trials, assays to determine the follow-on biologic’s potency, stability, etc.<\/i><\/p>\n

It seems to me that this could open up all sorts of shenanigans. And it appears to be more than regular generics have to do. From what I could determine, a company hoping for approval of a generic simply has to provide the patent numbers that cover the drug it is proposing to market. I could find nothing to indicate that it must turn over all the data of the generic to its direct competitor before going to market.<\/i><\/p>\n

How many companies will be willing to provide their direct competitor with all the information present in its application to the FDA? It seems to me a place where some mischief could occur.<\/i><\/p>\n

Now, I did not have time to review the complete history of these sections. I’m sure I could find all the committee testimonies on these parts. Perhaps someone out there has more detailed information. I’d love to pull an Emily Litella<\/a> and say “Never Mind.”<\/i><\/p>\n

So, this bill settled something really important for the biotech industry and, while bringing some clarity to the idea of biosimlars, also introduced some possible complications.<\/i><\/p>\n

I have to say it was fun to use the power of the Web to investigate the issue and form some opinions. Using technology to move information around faster is part of what SpreadingScience does.<\/i><\/p>\n","protected":false},"excerpt":{"rendered":"

by kaibara87 The opinion piece I wrote for Xconomy has been published. Luke Timmerman asked me on Monday to examine the bill and the sections that impacted the Biotechnology industry. I had not even realized there were parts of the huge healthcare reform bill. I started writing on Monday evening and got Luke my version … Continue reading My Op\/Ed in Xconomy<\/span> →<\/span><\/a><\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"spay_email":"","footnotes":"","jetpack_publicize_message":"","jetpack_is_tweetstorm":false},"categories":[10,3,4],"tags":[18,34,31,33],"class_list":["post-639","post","type-post","status-publish","format-standard","hentry","category-knowledge-creation","category-science","category-web-20","tag-biology","tag-knowledge-creation","tag-science","tag-web-20"],"jetpack_featured_media_url":"","jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pe2yp-aj","jetpack_likes_enabled":true,"jetpack-related-posts":[{"id":465,"url":"https:\/\/www.spreadingscience.com\/2008\/12\/12\/xconomys-event\/","url_meta":{"origin":639,"position":0},"title":"Xconomy's event","date":"December 12, 2008","format":false,"excerpt":"On Thursday, Xconomy held an event in Seattle where a panel discussed Vaccines 2.0. It was very interesting and I will wrote up more later. In the meantime, here are some photos: Well, I spent too much time talking out front and did not get a great seat. There was\u2026","rel":"","context":"In "Science"","img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":522,"url":"https:\/\/www.spreadingscience.com\/2009\/05\/12\/an-op-ed-i-wrote\/","url_meta":{"origin":639,"position":1},"title":"An op-ed I wrote","date":"May 12, 2009","format":false,"excerpt":"I have an article published online at the Xconomy Forum called Biotech Needs Charity, and Profit Motive, To Flourish. It discusses the possible role of non-profit research institutions in Seattle in new drug development. It also mentions a new corporate entity called an L3C that could have some impact in\u2026","rel":"","context":"In "Non-Profits"","img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":593,"url":"https:\/\/www.spreadingscience.com\/2009\/10\/15\/red-flags-of-understanding\/","url_meta":{"origin":639,"position":2},"title":"Red flags of understanding","date":"October 15, 2009","format":false,"excerpt":"by Luke Hoagland Five Red Flags to Watch Out For in a Biotech, From Dendreon Co-Founder Chris Henney [Via Xconomy ] Biotech, people, cancer Luke Timmerman wrote: Yesterday, we provided a rundown of the six hallmarks of a successful biotech company, according to Christopher Henney, the biotech pioneer who co-founded\u2026","rel":"","context":"In "Science"","img":{"alt_text":"","src":"https:\/\/i2.wp.com\/www.spreadingscience.com\/wp-content\/uploads\/2009\/10\/200910151301.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":681,"url":"https:\/\/www.spreadingscience.com\/2010\/10\/07\/the-conversation-i-moderated\/","url_meta":{"origin":639,"position":3},"title":"The conversation I moderated","date":"October 7, 2010","format":false,"excerpt":"Seattle Channel Video can be played in Flash Player 9 and up On September 14, I moderated a discussion between Ash Awad, Vice President of Energy & Facility Services at McKinstry; and Daniel Friedman, Dean of the College of Built Environments at the University of Washington. The topic was A\u2026","rel":"","context":"In "Knowledge Creation"","img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":231,"url":"https:\/\/www.spreadingscience.com\/2008\/06\/11\/fun-inside-the-firewall\/","url_meta":{"origin":639,"position":4},"title":"Fun inside the firewall","date":"June 11, 2008","format":false,"excerpt":"by Wolfgang Staudt IBM Builds LOTS of Social Apps: [Via chrisbrogan.com] My friend Luke sent me this BusinessWeek article about enterprise social network tools. There\u2019s lots here. First, take away from this that the social network technologies you know about in the consumer space are being rebuilt inside the firewall\u2026","rel":"","context":"In "Web 2.0"","img":{"alt_text":"","src":"https:\/\/i2.wp.com\/www.spreadingscience.com\/wp-content\/uploads\/2008\/06\/monument.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":188,"url":"https:\/\/www.spreadingscience.com\/2008\/05\/20\/social-media-sites-for-scientists\/","url_meta":{"origin":639,"position":5},"title":"Social media sites for scientists","date":"May 20, 2008","format":false,"excerpt":"myScience: \u201csocial software\u201d for scientists: [Via O'Really? at Duncan.Hull.name] With apologies to Jonathan Swift: \u201cGreat sites have little sites upon their back to bite \u2018em And little sites have lesser sites, and so ad infinitum\u2026\u201d So what happened was, Carole Goble asked on the myExperiment mailing list, \u201cis there a\u2026","rel":"","context":"In "Knowledge Creation"","img":{"alt_text":"","src":"https:\/\/i1.wp.com\/farm1.static.flickr.com\/192\/512341455_0493eeb389_m.jpg?resize=350%2C200","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/www.spreadingscience.com\/wp-json\/wp\/v2\/posts\/639"}],"collection":[{"href":"https:\/\/www.spreadingscience.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.spreadingscience.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.spreadingscience.com\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.spreadingscience.com\/wp-json\/wp\/v2\/comments?post=639"}],"version-history":[{"count":0,"href":"https:\/\/www.spreadingscience.com\/wp-json\/wp\/v2\/posts\/639\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.spreadingscience.com\/wp-json\/wp\/v2\/media?parent=639"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.spreadingscience.com\/wp-json\/wp\/v2\/categories?post=639"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.spreadingscience.com\/wp-json\/wp\/v2\/tags?post=639"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}