Manufacturers are not complaining too loudly about these costs because they gain a pathway for the US Food and Drug Administration
to authorize follow-on biologics (FOBs), the crown jewel in the bill for drug and biotech companies. After years of debate
on this issue, innovator firms won an unprecedented 12-year data exclusivity period for reference biotech products, with the
possibility of a six-month extension for sponsors who conduct pediatric studies. The Biotechnology Industry Organization (BIO)
focused its lobbying efforts on this historic provision, which was steered through Congress by Rep. Anna Eshoo (D-CA), despite
strong opposition from powerful legislators and the White House.
The Congressional Budget Office projects that the program will save the government—and cost manufacturers—$7 billion over
10 years. BIO President Jim Greenwood cheered the measure for providing "incentives necessary to attract the massive investment
required to speed the discovery and development of the next generation of breakthrough therapies." But Kathleen Jaeger, president
of the Generic Pharmaceutical Association, complained that the bill "locks down indefinite brand product monopolies at a deep
cost to patients and taxpayers." Timely access to biopharmaceuticals, claims Jaeger, could have produced 10 year savings well
over $50 billion.
All manufacturers, however, stand to benefit from clearer policies on developing and regulating biosimilars and "biobetters."
The FDA now has to issue guidance on what analytical assays and clinical studies will be needed to document FOB safety, purity
and potency, and what criteria could support product interchangeability, a critical issue for marketing and reimbursement.
Sponsors will pay the FDA user fees, there's a process for innovators to challenge patent infringement, and Medicare Part
B will pay for biosimilars at average sales price plus 6%—an amount considered high enough to encourage physicians to administer
less costly FOBs.
BIO also championed a relatively minor provision in the legislation that provides tax credits to small biotech companies (less
than 250 employees) to cover a portion of R&D expenditures. The bill establishes a two-year program that offers a total of
$1 billion in tax credits to cover expenses related to research on certain critical therapies.
Another plus for the industry is language clarifying that comparative effectiveness research resulting from an expanded national
program will not be used to determine coverage or reimbursement decisions by Medicare and other government health programs.
The new nonprofit, nongovernment Patient-Centered Outcomes Research Institute will set priorities and support comparative
studies with a $150 million annual budget as of 2012. All research will recognize differences in patient populations and will
be made public.
More troubling for manufacturers are new sunshine provisions that require broad, national disclosure of payments and reimbursement
from pharmaceutical marketers to physicians. The industry also is concerned about a new Independent Medicare Advisory Board,
formed to identify ways to slow the growth in Medicare spending. That could affect Medicare drug coverage, but the board won't
be up and running until 2014, providing time for Congress to make it more accountable.
Policymakers may not do that, though, as they are anxious to gain any and all savings for the healthcare system. The new law
does little to bend the cost curve on national healthcare spending. Instead, it pays for the program through cuts in Medicare
provider fees, which could be rescinded, and by imposing additional taxes on high-income consumers and healthcare companies.
Tax hikes, though, do little to curb overall healthcare spending, and may boost outlays even more.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, firstname.lastname@example.org