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The Rapid Reporter: April 2007

By Diane West
Published: Friday, Aug 13, 2010
THE RAPID REPORTER

BIO (Biotechnology Industry Organization) CEO & Investor Conference Recap

February 11-14, 2007

New York, NY


%u25BA Safety, Patent Disputes to Dominate Government’s Biologic Policies

     FDA to Review Safety of Biologic Oncology Drugs on May 10th; PDUFA Deadline Brings 

     Biologic “Follow-On” Drugs to The Fore


The safety of biologic drugs and the manufacture of ‘generic’ biologics−called follow-on biologics−will be subjects of great political debate for the rest of the year, according to public and private industry experts.

The issues have taken on added emphasis as the deadline to pass the Food and Drug Administration’s (FDA’s) Prescription Drug User Fee Act, or PDUFA, approaches. The Act, which comes before Congress every five years, determines how  fees collected by the FDA from drug makers will be spent. The Act expires on September 30th.

“If time runs out [on PDUFA] by the end of the fiscal year, FDA reviewers must be let go,” Nick Littlefield, a partner with the Washington-based law firm Foley Hoag. Mr. Littlefield was part of a Feb. 12th panel discussion during the “BIO CEO & Investor Conference 2007” in New York called “The New Congress: Implications for the LifeSciences Industry.” The panel included James Greenwood, President and CEO of the Biotechnology Industry Organization (BIO); Alex Azar; former Deputy Secretary,

Department of Health and Human Services; Steve Usdin, Washington Editor, BioCentury Publications Inc.; and Thomas A. Scully, J.D., Senior Counsel, General Partner, Alston & Bird LLP, Welsh, Carson, Anderson & Stowe.

Two bills in particular, one by New York Democratic Senators Hillary Clinton and Charles Schumer, the other by Senators Edward Kennedy (D-MA) and Mike Enzi (R-WY), address biologics and may delay the passage of PDUFA this year. (See our accompanying story in “Politics & Policy” for more.)

The Clinton-Schumer bill, called “The Access to Life-Saving Medicine Act” would grant FDA the authority to approve follow-on biologics and “create a new statutory pathway for approval of ‘generic’ versions of biotech drugs.” This will speed lower-cost follow-on biologics to market and relive financial burdens on patients, the Medicare system, and private insurers alike, say supporters.

But the “Access” Act is being vigorously contested by BIO, which represents more than 1,000 biotech companies and their partners.

“Attaching follow-on biologics legislation to PDUFA would potentially jeopardize reauthorization of the user fee program to the detriment of patients waiting for new therapies, FDA’s internal scientific capabilities, and biomedical innovation,” Mr. Greenwood told the Senate’s Health, Education, Labor and Pensions Committee on March 8th.

BIO favors the Kennedy-Enzi bill, “The Enhancing Drug Safety and Innovation Act”, which they say takes patient safety  into consideration while “providing incentives [to biologic drug developers] for the innovations that will bring the medical miracles of tomorrow,” according to Sen. Kennedy.

Participants in the New Congress panel agreed that passing either bill before PDUFA expires will be difficult. Part of the difficulty will be explaining the difference between the manufacture of traditional drugs and biologics—let alone ‘generic’ versions of each—to lawmakers.

“The most congressional leaders know about biologics,” Mr. Azar said, “has been over the ‘food fight’ between Amgen’s Aranesp® (darbepoetin alfa) and Johnson & Johnson’s/Ortho Biotech’s Procrit® (epoetin alfa).”

Both Aranesp and Procrit, erythropoiesis-stimulating agents (ESAs), treat chemotherapy-induced anemia by stimulating the bone marrow to make more red blood cells. J&J sued Amgen late last year for what they allege were unfair sales practices meant to force Procrit offthe market. “The biggest amount of spending the government does has been over the fight between Aranesp and Procrit,” added Mr. Azar.

On March 9th, the FDA ordered both companies to provide stronger warnings for both Aranesp and Procrit in light of the higher number of life-threatening side effects and deaths among patients receiving either therapy. The FDA is planning to review the safety and efficacy of ESAs at the FDA’s Oncologic Drugs Advisory Committee (ODAC) on May 10, 2007.





%u25BA Hazy Predictions from Preclinical/Early Clinical Trials Hamper Investment in Biologic Cancer

    Research and Development


    Are preclinical trials actually valuable predictors?



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