Date: 14 February 2011
Source: Reuters
Link: http://www.reuters.com/article/2011/02/14/usa-budget-healthcare-idUSN1430012220110214
Big pharmaceutical companies could face increased competition from generic
drugmakers under two proposals put forth by the Obama administration on Monday
despite earlier savings extracted from drugmakers as part of last year`s
healthcare law.
President Barack Obama, as part of his 2012 budget proposal, called for
cutting the number of years drugmakers could exclusively market brandname
biologic drugs to 7 years from 12.
He also set his sights on ending controversial "pay-for-delay"
deals that affect traditional, chemical drugs by giving the U.S.
Federal Trade Commission power to block them. Under such pacts, brandname
and
generic drugmakers settle patent challenges with payoffs that delay lower-cost
rivals from reaching the market.
The proposals face a tough challenge of getting through the divided Congress,
but could alter the landscape for consumers` access to cheaper medicines.
They quickly drew industry protests.
While branded and generic drugmakers are divided over the biologics issue,
"both the brand and generic drug industries will fight tooth and nail
to preserve pay-to-delay settlements which provide substantial benefit to
the industry," Bernstein analyst Aaron "Ronny" Gal said in
a research note.
Still, they are unlikely to deliver a huge overall blow to the $890 billion
global drug industry in which companies such as Pfizer Inc (PFE.N: Quote,
Profile, Research, Stock Buzz) and Merck & Co Inc
(MRK.N: Quote, Profile, Research, Stock Buzz) can see at least $1 billion
a year in revenue from just one blockbuster medicine.
The Obama administration is turning to drugmakers to help squeeze out some
savings to help reduce the deficit and cover other health initiatives such
as the implementation of the health law passed last March that included
about $80 billion in savings negotiated with brand name companies.
U.S. Health Secretary Kathleen Sebelus was unapologetic about the extra
savings from industry, and saying the administration wants the best
outcomes for patients. "This is a move in that direction," she told
reporters.
The two proposals aimed at getting cheaper, generic medicines to the U.S.
market would together save about $11 billion over 10 years.
The proposal impacting brandname biologics is a more dramatic version of a
similar provision included in the health law in which brandname drugmakers
won 12 years of exclusive sales under an new U.S. Food and
Drug Administration approval process to allow generic versions of biologics.
Such medicines treat conditions ranging from cancer to arthritis and are
made from proteins, which can make them more complex to manufacture and
more costly.
Generic drugmakers had fought for a shorter period of exclusivity, and on
Monday the administration said 12-years of protection harms consumer
access to much needed drugs.
Its 7-year proposal "strikes a balance between promoting affordable access
to medication while at the same time encouraging innovation to develop
needed therapies," the White House said in budget documents.
The measure would start to see savings of $80 million starting in 2015 and
altogether could save $2.3 billion from 2012 to 2021, it estimated.
The "pay-for-delay" plan would save $540 million starting in
fiscal 2012 and nearly $8.8 billion through 2021, it added.
In a statement, branded industry group the
Pharmaceutical Research and Manufacturers of America said both measures
would discourage industry investment into research and development and
could stifle new medicines.
The Biotechnology Industry Organization said reducing exclusivity to 7 years
would prevent biotech firms from recouping their investments. Meanwhile,
the Generic Pharmaceutical Association applauded the 7-year
biogeneric plan but called Obama`s move on "pay for delay" misguided.
The patent plan was likely weighing on shares on Monday for some generic
drugmakers that benefit more from the "pay for delay" payouts, said
Bernstein`s Gal.
Shares of such as Watson Pharmaceuticals (WPI.N: Quote, Profile, Research,
Stock Buzz) were down 1.6 percent in afternoon trading while Mylan (MYL.O:
Quote, Profile, Research, Stock Buzz) was up 0.2
percent. Others such as Teva Pharmaceutical Industries (TEVA.TA: Quote,
Profile,Research, Stock Buzz) and Hospira (HSP.N: Quote, Profile,
Research, Stock Buzz) are less exposed, said Gal, adding that savings from
ending the deals may be even larger.
Obama`s budget also renewed the call for generic drugmakers to pay fees
for the FDA to review new generic medicines.
Other proposed fees would cover FDA reinspections of drug and device companies
after manufacturing problems are uncovered. Hospitals and others
participating in an outpatient drug pricing program known as
340B are also targeted.
Additionally, the administration calls for food safety industry fees starting
in 2013 and pledged to work with Congress to enact them.
Keywords: Pharmaceutical / Medicines / Obama /
Budget
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