Alittle more than a year ago, leaders of the pharmaceutical industry negotiated a deal to provide billions of dollars in discounts
and fees designed to make drugs more affordable to Americans. In return, manufacturers anticipated a larger market for prescription
medicines in a reformed national healthcare system, plus favorable policies governing research and development (R&D) and marketing—
without explicit price controls.
Now there's considerable uncertainty about how the Obama healthcare-reform program will be implemented, and how well the system
will support biomedical innovation and new drug development. Federal courts are weighing the constitutionality of the Affordable
Care Act (ACA), while reform critics in Congress are challenging specific policies and curbing funds needed to implement reform
initiatives. Some states face serious budget problems and are looking to limit Medicaid programs, including drug benefits.
The Obama administration's budget plan for 2012 offers extra funding for biomedical research and for FDA operations, but it's
uncertain whether these proposals will survive the budget-cutting battle on Capitol Hill.
Killing the deal
The search for additional funds to pay for healthcare-reform initiatives and government health programs, moreover, is driving
the Obama administration to ask Big Pharma to ante up even more. During the healthcare-reform debate of 2009, the Pharmaceutical
Research and Manufacturers of America (PhRMA) agreed to pay higher Medicaid rebates and additional taxes, and to subsidize
the cost of drugs prescribed to seniors caught in the "doughnut hole" of the Medicare drug benefit— all adding up to some
$80 billion over 10 years. A primary gain for biomedical companies was the promise of substantial protection for innovator
biotech therapies in the face of more aggressive generic competition.
The administration now proposes to jettison the biotech exclusivity deal and boost consumer access to generic drugs to help
gain some of the $54 billion needed to support Medicare payments to physicians. Shrinking the exclusivity for innovator biologics
from 12 to seven years and thus speeding less costly biosimilars to patients, according to Obama's 2012 budget plan, would
save about $2.3 billion over 10 years. The Biotechnology Industry Organization (BIO) warned that such "questionable short-term
budgetary savings" could jeopardize development of new breakthrough cures.
John Castellani, president of PhRMA, said in a press release that the proposal "flies in the face" of the administration's
talk about supporting "innovation, biomedical research, jobs and US competitiveness." But US Health and Human Services (HHS)
Secretary Kathleen Sebelius told the House Energy and Commerce (E&C) Committee last month that the administration now feels
that a seven-year exclusivity period will permit innovator firms to realize an appropriate return on investment, while ensuring
that new breakthrough medicines are widely available and affordable.
In Washington this month
Another administration proposal would end pay-for-delay deals between brand-name and generic drug makers that postpone when
a new generic product comes to market. The Generic Pharmaceutical Association (GPhA) applauded the shorter biotech exclusivity
period, but criticized the curb on settlements as "misguided." Castellani agreed with the generic-drug makers, noting that
these "pro-consumer settlements" do not delay generic entry and often bring low-cost drugs to market sooner. Federal Trade
Commission officials, however, have been pushing hard to curb such arrangements, which they insist are anti-competitive and
costly to consumers. The numbers-crunchers predict that banning pay-for-delay deals will save the government $540 million
next year and nearly $8.8 billion through 2021.
The generic-drug gains together provide only a small portion of the resources needed to finance the "doc fix." Most of the
money would come from proposed reductions in federal payments to state Medicaid programs, stiffer scrutiny of certain Medicare
reimbursement to insurers, and proposals to reduce Medicare fraud and abuse. The plan also proposes to increase tracking of
high prescribers in Medicaid programs to reduce excessive drug utilization by states. And manufacturers would be hit with
additional penalties if they fail to pay appropriate Medicaid drug rebates and to comply with rebate rules and FDA policies
for listing drugs on databases. But these policies generate virtually no tangible savings, and it's questionable whether the
squeeze on biotech exclusivity is worth the rather small budgetary gain to the government.