My letter to the editor of The Hill is a start....
The fact that there have been fewer patent challenges to biologics than for pharmaceuticals is not a rationale for weakening patent protection for biologics..... Is that the new standard for economic and science policy for the Obama administration? Or is it all about cost?
Eshoo drug legislation better than Waxman alternative bill
By Robert Goldberg, Ph.D., co-founder, Center for Medicine in the Public Interest
Posted: 06/30/09
An important part of the healthcare debate is the two competing pieces of House legislation that give the Food and Drug Administration the authority to create modernized pathways for the creation of generic forms of biologic medicine drugs.
Known as follow-on biologics, or biosimilars, the FDA currently cannot approve these important medicines because of safety concerns over the difficulty in replicating these types of drugs.
House Energy and Commerce Committee Chairman Henry Waxman (D-Calif.) believes the language in his follow-on biologic bill should be included in the broader healthcare legislation in order to reduce the cost of one of President Obama’s top policy agenda items.
On the other hand, Rep. Anna Eshoo (D-Calif.) believes her legislation should go through the standard process of committee markup and onto the House floor on its own, allowing for full vetting and debate on one of the key healthcare reforms of this generation.
Both pieces of legislation have their merits and both members should be commended for their willingness to take a lead on this important issue, but Eshoo’s bill has the right prescription for getting follow-on biologics to the market.
First, the Eshoo legislation puts a priority on patient safety by requiring appropriate and stringent clinical trials and testing. This is necessary because biologic drugs are created from living organisms such as proteins and carbohydrates, and are not as simple to replicate as traditional drugs like aspirin and antihistamines.
Second, by protecting adequate data exclusivity, innovator companies will not be forced to charge more for their biologic treatments.
Third, Eshoo’s legislation rewards new biologic innovation by drug companies because it grants them a longer period of data exclusivity to continue research and development to fight other diseases.
Fourth, Eshoo’s legislation gives hope to those suffering from rare diseases or conditions. If drug companies think they will have a short time before a generic version of their product is on the market, they will only focus on the drugs for major diseases and conditions, potentially ignoring ailments that are less common, but equally as serious, to those suffering.
Follow-on biologic legislation must be about balancing patient safety and cost reduction. To ignore either one — or to unnecessarily rush creating this pathway — will only hurt those patients who depend on follow-on biologics the most.
