SOURCE: Five Star Equities

Five Star Equities

May 24, 2012 08:20 ET

Plan to Speed Up FDA Reviews for New Drugs and Medical Devices Moved to Senate

Five Star Equities Provides Stock Research on Bristol Myers Squibb and Pfizer

NEW YORK, NY--(Marketwire - May 24, 2012) - Lost revenues as a result of expiring patents have been a growing problem for the big pharmaceutical companies. New products that are being introduced into the market place are not expected to generate the same levels of revenues of top selling drugs that have lost patent protection, but a plan to speed up reviews of new drugs and medical devices will look to benefit the industry. Five Star Equities examines the outlook for companies in the Drug Manufacturers Industry and provides equity research on Bristol Myers Squibb Co. (NYSE: BMY) and Pfizer Inc. (NYSE: PFE).

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A $6.4 billion plan to speed up FDA reviews of new drugs and medical devices is now a step closer to becoming law as it has now been moved to the Senate. The Senate was expected to vote earlier this week on roughly $2 billion in new fees that drug and medical device companies will pay to regulators over the next 5 years for review of their products according to a recent Bloomberg article. Generic-drug companies, who were previously exempt from such fees, make up $1.56 billion. Fees for brand-name drug companies over the five-year period will increase 6 percent to $4.1 billion, and more than double for device makers to 609 million, according to the Congressional Budget Office's cost estimate.

"To get lifesaving drugs and devices to the patients that need them as quickly as possible, Congress must give the Food and Drug Administration the tools it needs to review and approve these products," Senate Majority Leader Harry Reid stated on the Senate floor.

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Bristol-Myers Squibb Company recently announced that the U.S. Food and Drug Administration (FDA) have approved the company's biologics manufacturing facility in Devens, Massachusetts for commercial production of ORENCIA (abatacept). "The approval of our Devens site is an important milestone for Bristol-Myers Squibb as part of our strategic focus on delivering innovative biologic medicines for patients with serious disease," said Lou Schmukler, president, Global Manufacturing & Supply, Bristol-Myers Squibb. "The increased manufacturing capacity from the Devens site will support market demand for ORENCIA and positions us well for future production of additional biologic medicines."

Pfizer recently announced that the Arthritis Advisory Committee to the U.S. Food and Drug Administration (FDA) voted 8-2 to recommend approval of the investigational agent tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The Committee's recommendation will be considered by the FDA in its review of the New Drug Application (NDA) for tofacitinib.

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