At the FEHBP conference, I learned about a new legislative initiative that frankly was not on my radar screen — permitting the Food and Drug Administration to approve generic versions of expensive biological or specialty drugs. A biological drug is “a substance that is made from a living organism or its products and is used in the prevention, diagnosis, or treatment of cancer and other diseases. Biological drugs include antibodies, interleukins, and vaccines.” Biological drugs tend to be quite expensive.
In 1984 the Hatch Waxman Act “opened the pathway” for FDA approval of generic versions of drugs made from chemical compounds, but not biologicals. Rep. Waxman has introduced a bill (H.R. 1038) to open the same pathway for biologicals, nicknamed biogenerics. The Senate HELP committee held a hearing on the issue and a related Senate bill yesterday, and at the FEHBP carrier conference several speakers talked about the importance of this bill in reducing health care costs. The biological drug manufacturers contend that biogenerics will impair their development efforts and also that it is more difficult to prove that biogenerics are equivalent to the brand name generic which is the quid pro quo for generic status. Biogenerics are on my radar screen now.