Whether you like President Obama or not, the changes he made in the leadership at the US Food and Drug Administration (FDA) is beginning to yield results. After just two years, the agency is well on its way to modernization and overcoming its descent into the dark ages during the failed Bush Administration.
Mark Senak, the intrepid author of the EyeonFDA blog has been assiduously following and blogging about many of the new things going on at the agency. First, in a post a last week, Mark noted that FDA has updated its website and created a product recall page that collects recall information on all of the products that it regulates and deposited it in an easy to find product recall page. With product recalls in the food and life sciences industry increasing in frequency, this page will help to alert consumers about tainted products before learning of them on the nightly news.
Second, Mark points out that FDA has finally entered the 21st century and is now fully engaged in social media.
“FDA begins to join the 21st Century launching a Facebook page that has been long anticipated on this blog. FDA has not completed the Social Media Quadrant - (1) a blog, (2) several twitter feeds (3) a YouTube channel, and (4) a Facebook page. And as added good measure, the agency opened a Flickr page. The agency is now fully engaged in activities that many in the industry it regulates think is forbidden them.... And the beat goes on.”
Finally, earlier this week FDA announced that it would hold long-awaited public hearings to get input on proposed biosimilar regulatory guidance. As Mark duly notes, this process is likely to be contentious and protracted.
"The FDA has set November 2-3 for a meeting to get input on a wide span of questions regarding the development of a regulatory pathway for biosimilars. The scope of the questions is demonstrative of the number of outstanding issues the agency faces and will likely result in a protracted process. "
Central to the debate (and ultimate success of biosimilars) is the question of interchangeability and substitution of name brand products with biosimilar molecules. According to Mark, the agency will focus on the following questions
"What factors should the agency consider in determining whether a proposed interchangeable biological product can be "expected to produce the same clinical result as the reference product in any given patient?"
"What factors should the agency consider in evaluating the potential risk related to alternating or switching between use of the proposed interchangeable biological product and the reference product or among interchangeable biological products?"
What has become patently obvious to many of us who have been following the debate over the last decade is that unless biosimilars are interchangeable or substitutable for brand name biologics, the commercial success of the biosimilar industry may be in serious jeopardy. Put simply, there is no question that safe and effective biosimilars can be manufactured; the real question is whether or not physicians will prescribe biosimilar products if they are required to be branded by regulatory agencies. This is because physicians are reluctant to switch patients to new biologic products if a patient is doing well on a currently prescribed regimen. Since most physicians pay little attention to drug pricing, it is highly unlikely that they will switch a patient to product simply because there may be a 20 percent reduction in drug price. And, unless biosimilar products are deemed interchangeable with their branded counterparts, pharmacists (based on insurance formularies) will not be able to offer patients a generic equivalent of a name brand biologics.
With the cost of biologic treatments skyrocketing, it will be interesting to see what the agency will do with this question.
Until next time...
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