Seven years is an appropriate length of time to protect brand-name biologic drugs from generic competition, senior White House officials have said.

Seven years’ exclusivity “strikes the appropriate balance between innovation and competition,” according to Peter Orszag, director of the White House Office of Management and Budget (OMB) and Nancy-Ann DeParle, director of the Office of Health Reform, who add: “innovation is driven by appropriate competition, and the administration's policy will spur that competition.”

The officials’ comments are made in a letter to Representative Henry Waxman, chairman of the House Energy and Commerce Committee, who in March introduced legislation to establish a pathway for the Food and Drug Administration (FDA) to approve generic versions of biologic drugs. His bill, the Promoting Innovation and Access to Life-Saving Medicine Act (HR 1427), would provide five years’ market exclusivity for branded biologics.

However, the industry is calling for 12-14 years’ exclusivity, and Jim Greenwood, chief executive of the Biotechnology Industry Organization (BIO), said yesterday that he was “extremely concerned” at the seven years’ exclusivity called for by the Administration.

“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,” said Mr Greenwood. _

“We continue to believe that 14 years of data exclusivity will strike the appropriate, reasonable and fair balance between our common desire to expand access to breakthrough biotech medicines and the need to preserve the protections necessary to promote further biomedical advances. In addition, it will provide biologics manufacturers with the same effective protections provided to small molecule drug manufacturers,” he added.

BIO is backing the Pathway for Biosimilars Act (HR 1548), which was also introduced in the House in March by Democrats Anna Eshoo and Jay Inslee and Republican Joe Barton and would offer 14 years’ data protection. Mr Greenwood points out that this bill has 110 bipartisan cosponsors and is supported by “more than 105 patient advocacy, physician, academic and innovator groups.” However, the Generic Pharmaceutical Association (GPhA) has attacked it, saying it will establish a long approval route “filled with needless roadblocks that will keep patients from getting needed medicines in a timely manner.”

In their letter to Rep Waxman, which was released yesterday, Mr Orszag and Ms DeParle also assure him that the Administration is working closely with the FDA, and that “a serious review of FDA's existing authorities is underway,” to ensure that a regulatory pathway for generic biologics can be introduced “as quickly as possible.”

Earlier this month, Rep Waxman had written to the officials, emphasizing that "when" his bill passes, the FDA must begin implementing the approval pathway programme as soon as possible. “I urge the Administration to consider what steps can be taken under existing authority to prepare and even begin to use a pathway for generic biologics. The speed of FDA's action will determine how quickly safe and effective generic biologics become available to patients,” he wrote.

Commenting on the officials’ responses, Rep Waxman said in a statement that the 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.”