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FDA Plans to Act Faster on Biotech-Drug Approval
Friday September 6, 12:48 am ET
WASHINGTON -- The Food and Drug Administration is planning to switch approvals of biotechnology drug products from its biologics division to its drug division, a change that could help speed the approval of biologic-drug applications, people who have been briefed on the matter told The Wall Street Journal.
The change, which could be announced as early as today, is considered important to the biotechnology industry, which has complained about the slow approval process and inconsistent standards between the two divisions -- one focused on traditional drug products, the other on relatively new biotechnology products.
A person briefed on the change yesterday said that biotechnology companies have "complained for years" that their approvals took longer compared with reviews for traditional drugs. Industry officials have seen the drug division as more responsive to industry and better managed. While the biologics center has often pointed out that biologics products rely on newer, more complex science, the industry has said the division simply doesn't move as quickly.
The biologics division was also singled out for criticism recently by the House Energy and Commerce Committee, which was investigating the stock-market collapse of ImClone Systems Inc. While much of that investigation has centered on insider trading allegations, the committee also found that the division's approval process "needed improvement." The trading occurred just before the division refused to consider an ImClone cancer-drug application.
Outside of the criticisms of the biologics division, industry and congressional sources said it makes sense to have the same set of standards apply to all drug products coming to the FDA for approval. Right now, the feeling is that applications are subject to different scientific standards and levels of proof between the two divisions.
An FDA spokesman had no comment.
Wall Street Journal Staff Reporter Chris Adams contributed to this report.<<
Cheers, Tuck |
