Boards
News
Market Data
Markets
Discover
Discover
AI Subscribe Login/Register account icon
S&P 500
6,368.85
(
-1.67%
)
US TECH 100
22,405.20
(
-2.38%
)
Dow Jones
45,166.64
(
-1.73%
)
Brent Oil
106.89
(
0.00%
)
Bitcoin
66,774.72
(
0.66%
)
News Focus
News Focus
Post# of 257301
Next 10
Public Reply Private Reply New Post
Keep Last Read
Keep Next 10 Report Keyboard Shortcuts
Next 10 Prev Next

DewDiligence

Send PM Follow Ignore
Followers 843
Posts 122817
Boards Moderated 10
Alias Born 09/05/2002

DewDiligence

Member Level

Re: Biopharm investor post# 23198

Friday, 02/17/2006 6:55:44 AM

Friday, February 17, 2006 6:55:44 AM

Post# of 257301
FDA Seeks User Fees From Generics Makers

[If the FDA agreed to four-month reviews of generic applications, as Gottlieb suggests they might in return for new user fees from ANDA applicants, it would change the U.S. generic-drug industry substantially. Is Gottlieb’s carrot for real, or is it just a negotiating ploy? Note the reference to Citizens’ Petitions in the last paragraph—this is clearly a sore spot for the generic industry. Please see #msg-9566322 for a graphical depiction of the magnitude of the problem.]

http://online.wsj.com/article/SB114014881471276778.html

>>
Companies Have Urged Speedier
Drug Approvals but Are Likely
To Greet Plan Skeptically

By ANNA WILDE MATHEWS
February 17, 2006

WASHINGTON -- The Food and Drug Administration wants generic-drug makers to pay user fees to fund reviews of their products.

The move comes as the industry is calling for speedier approvals and a larger agency staff commitment to review generics. But the agency's plan is likely to draw a skeptical response from generics makers, which have never paid such fees.

Major branded-pharmaceutical companies and device makers have paid FDA user fees for years, and the laws that govern both expire in September 2007. The FDA and the generics industry likely would have to negotiate the structure of potential user fees before Congress would take up the issue.

The political focus on generics is rising, fueled by continued concern over the cost of drugs and the new Medicare consumer drug benefit. In a House hearing yesterday, the FDA's acting commissioner, Andrew von Eschenbach, was asked about the agency's handling of generic drugs, including its plans for copies of biotech drugs. Dr. von Eschenbach defended the agency's current handling of generic drugs, saying there is "no gap and no delay" in their availability once legal issues are resolved.

The agency hasn't yet issued guidelines for how companies should test copies of biotech products, a few of which could potentially be approved through the current legal generics pathway.

In a speech today at the Generic Pharmaceutical Association's annual meeting, FDA Deputy Commissioner Scott Gottlieb is expected to signal the agency's interest in generic-maker user fees, saying the FDA needs to "make sure that the generic-drug program remains on stable financial footing," according to a draft of the speech.

After discussing user fees, he is expected to say that the agency "can do more with more" and say that the agency's "new drugs program has benefited from funding tools that are not available to us when it comes to generic drugs."

Dr. Gottlieb is also expected to lay out some of the concessions the agency might make in exchange for the fees: perhaps commitments to review first generic applicants in cases without patent protection in four months. The agency could also work on research about how to prove a generic version is equivalent to an original drug, and it plans to smooth communication between reviewers and generic-drug makers.

It is unclear if generic-drug makers will agree to the fees. The industry has complained recently about growing backlogs of its drugs at the FDA and has called for more funding from Congress for the office that reviews generics. "We're not sure that if we agreed to pay user fees that the FDA could guarantee that our products could get to consumers any faster," said Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association, before Dr. Gottlieb's speech.

She said generics makers likely would consider paying user fees if the FDA and the Bush administration would endorse legislative and other changes that the industry believes would speed its products. Among the companies' complaints are petitions filed by branded-pharmaceutical makers, which can delay approval of generics. The FDA says much of the backlog is older drugs that already have generic competitors or generic drugs that can't go on the market yet because the brand drug's patent isn't close to expiring.
<<

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

Public Reply Private Reply New Post
Keep Last Read
Keep Last Read Next 10 Report Keyboard Shortcuts
Next 10 Prev Next

Discover What Traders Are Watching

Explore small cap ideas before they hit the headlines.

Join Today