On the Ides of March, Genetic Engineering and Biotechnology News (GEN) published an article by Ronald A. Rader, President of the Biotechnology Information Institute that provided an overview of the product approval rate focusing solely on biologics.
For a long time, one has heard of the promise of biotechnology – in the case of medical treatments – products made from living cells rather than chemical compounds. However, this article points out that the approval by FDA of biopharmaceutical products has declined in recent years from a ten-year span that includes 1996-2005 where an average of 16.6 approvals occurred each year, to only 12 and 11 in 2006 and 2007, respectively.
The biotechnology pipeline is supposed to be crowded with promise and a large number of investigational products. What are the prospects for getting these products approved and to market?
Recently Eye on FDA profiled the IMS report that also revealed a slow-down in pharma sales. One reason for such a decline in growth is the fact that there are fewer products entering the market. This has an impact not only on physicians and their patients, but also investors. Biotechnology has been an area of keen interest for investors.
There have been clear signals that the FDA is going to take longer periods of time to approve new products, even going outside of PDUFA action date parameters in order to assure safety. This will have a direct impact on investors and on the value of the intellectual property that is at stake, given the fact that the patent time begins running well before FDA approval. The less time the product has on the market with its patent in tact, the more expensive the medical product will be in a balancing act that pits the interests of patients directly against that of investors.
If you lessen the flow of water upstream, it has an inevitable effect on the people located downstream. In our zeal for a risk-free environment, policy makers cannot intimidate the FDA so badly that the agency cannot function to bring meaningful advancement and the realization of medical interventions in a timely fashion.
On a related note, recently, Eye on FDA had a posting about the promise of pharmacogenomics. The posting cited a primer developed by the National Health Policy Forum that described the policy hurdles that exist and questions the possibility that that medical progress in that area might be compromised by a lack of drive to address progress on the policy front.
When Will We Have the Option of Generic MS Self-Injectable Drugs?
So you learn you have developed multiple sclerosis – MS.
I would like to know how I could write to the FDA. My husband is hoping to be part of a clinical trial for stem-cell implants and gene therapy for his Stargardt’s syndrome (juvenile macular degeneration). I’d like to find out how close the FDA is to approving this clinical trial. This procedure could dramatically improve my husband’s quality of life.