By
Donald Zuhn --
President
Obama's new proposal for health care reform was unveiled on the White House
website earlier this
week. According to the White House, the President's plan "builds off of the legislation that passed the Senate
and improves on it by bridging key differences between the House and the Senate
as well as by incorporating Republican provisions that strengthen the proposal." The President's new proposal is being
offered in anticipation of Thursday's "open, bipartisan" meeting to
discuss ideas for reforming and improving the U.S. health care system.
Among
34 "key improvements"
in the President's plan is a proposal to prevent delays in the public's access
to generic drugs by banning pay-for-delay settlements, wherein a brand-name
pharmaceutical company can delay generic competition through an agreement to
pay a generic company to keep its drug off the market for a period of time. According to the President, support for
a pay-for-delay ban comes from a Federal Trade Commission (FTC) report that estimates
that such agreements could cost consumers $35 billion over the next 10
years. The President's plan adopts
a provision from current health care reform legislation wherein "any
agreement in which a generic drug manufacturer receives anything of value from
a brand-name drug manufacturer that contains a provision in which the generic
drug manufacturer agrees to limit or forego research, development, marketing,
manufacturing or sales of the generic drug" would be presumed to be "anti-competitive
and unlawful." This presumption
could "be overcome if the parties to such an agreement demonstrate by
clear and convincing evidence that the pro-competitive benefits of the
agreement outweigh the anti-competitive effects of the agreement." The President's proposal would also
give the FTC enforcement authority to address pay-for-delay agreements.
According
to the President's proposal, the plan also "promotes innovation [and] creates a
pathway for the creation of generic versions of biological drugs so that
doctors and patients have access to effective and lower cost alternatives." However, as presently described, the
plan provides no further details regarding how it would promote
innovation and lacks specifics regarding the follow-on
biologics (or biosimilar) regulatory pathway it would establish. Earlier this year, the President
created some controversy when he informed Congressional Democratic leaders,
including Rep. Anna Eshoo (D-CA), of his continued opposition to a 12-year data
exclusivity period in a meeting at the White House (see "Snatching Defeat from the Jaws of Victory?"). The President's position was not too
surprising, given the Administration's assertion in a letter to House Energy
and Commerce Chairman Henry Waxman (D-CA) last June that a 7-year data
exclusivity period would "strike[] the appropriate balance between
innovation and competition" (see
"White House Recommends 7-Year Data Exclusivity Period for Follow-on
Biologics").
The President's
Bipartisan Meeting on Health Reform
will take place on Thursday, February 25, beginning at 10:00 am (EST). The meeting, which will be held in the
Blair House, will be open to the public and made available online at www.whitehouse.gov/live. The meeting webpage on the White House
website includes links to health care ideas being currently presented by Senate
Democrats, Senate Republicans,
House Democrats, and
House Republicans.
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