WASHINGTON (Reuters) - Seven years is an appropriate time period to protect brand-name biotechnology medicines from cheaper generic rivals, White House officials said in a letter released on Thursday.
The amount of protection for brand-name companies is a sticking point among lawmakers working to set up a legal pathway for approval of generic forms of biotech drugs. The brand-name versions can cost tens of thousands of dollars per year.
Industry groups representing brand-name makers are lobbying for 12 to 14 years, saying it is crucial for encouraging companies to invest in development of new medicines.
White House officials, in a letter to Representative Henry Waxman, said seven years “strikes the appropriate balance between innovation and competition by providing for seven years of exclusivity.”
“Innovation is driven by appropriate competition, and the administration’s policy will spur that competition,” said the letter from Office of Management and Budget Director Peter Orszag and Nancy-Ann DeParle, director of the Office of Health Reform.
Biologics are man-made forms of human proteins that are tougher to produce than traditional, chemical-based medicines. The drugs treat conditions ranging from anemia and rheumatoid arthritis to cancer.
Waxman, chairman of the House of Representatives Energy and Commerce Committee, has written legislation providing up to five years of protection from rivals for brand-name drugs.
The Biotechnology Industry Organization, which represents brand-name companies, “is extremely concerned” that seven years would be a “risky short cut,” BIO President Jim Greenwood said in a statement.
“We believe this abbreviated period will undermine the incentives necessary for continued biotech research into breakthrough medicines and cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS as well as unmet medical needs,” Greenwood said.
Waxman, in a statement, said the Obama administration “has made clear that the president does not support the lengthy monopoly periods sought by the drug industry and instead wants a bill, as I do, that will bring real competition and will not unduly prolong the monopolies on biotech drugs.”
Reporting by Lisa Richwine; Editing by Bernard Orr