- Biogen Idec Closing San Diego Center, Cadence Wins FDA Approval, Adventrx Files New Drug Application, More San Diego Life Sciences News
- San Diego’s Zogenix Files for $90M IPO to Expand Development of Needle-Free Injector and Pain Drugs
- Amylin and Biogen Idec Make Board Changes, Inovio Catches Wave of Investor ‘Swine Flu’ Fervor, Ligand Buys Neurogen, Other San Diego Life Sciences News
- Eastbourne Dumps Amylin Shares, Illumina Inks Licensing Deal, Avanir Releases Pseudobulbar Affect Data, More San Diego Life Sciences News
- Celladon Enjoys Early Success With Gene Therapy Trial, FDA Gives Digirad Green Light for a Nuclear Camera, Aragon Pharmaceuticals Gets $22M More San Diego Biotech News
The life sciences industry says its working relationship with the U.S. Food and Drug Administration has improved, particularly for the early stages of the agency’s product review process. But a survey of 50 life science companies, primarily in California and Massachusetts, also pointed to rising concerns about the latter part of the product review process, as well as about the agency’s ability to keep up with the pace of scientific and technological innovation.
The Pricewaterhouse Coopers accounting firm conducted the survey, the fifth since 1995, with help from San Diego’s Biocom and the Massachusetts Biotechnology Council. While participants included companies developing small-molecule drugs, biologics, medical devices, and diagnostics, Biocom CEO Joe Panetta said, “We tend to focus on the smaller companies that actually had a product in review since the previous survey was done.”
The latest survey, which was completed a few months after Congress passed federal health care reform legislation, also highlighted industry concerns over a requirement for the FDA to establish a process for approving generic versions of biotech drugs (aka biosimilars or follow-on biologics). Participating companies also reacted unhappily to provisions of the Patient Protection and Affordable Care Act that provide funding that could add “comparative effectiveness” as a criterion in the approval process.
Industry concerns that were focused a decade ago primarily on the early stages of regulatory review have shifted now to the latter stages of the review process, Panetta said. The most-recent survey found that 78 percent of the participating companies agreed that FDA guidance documents have increased their understanding of FDA expectations during the drug development process. More than two-thirds (68 percent) said they have done a better job of incorporating regulators’ feedback
But more than 60 percent of the respondents said the FDA changed its position during at least one review, and 56 percent said the regulatory approval process lags scientific and technological advances.
“The last two surveys have shown us some performance issues that have led us to focus on the agency’s ability for timely review of products,” Panetta said. He cited …Next Page »
Bruce V. Bigelow is the editor of Xconomy San Diego. You can e-mail him at firstname.lastname@example.org or call 858-202-0492
- FDA: Majority Of Drug And Biological Product Makers Meeting Postmarketing Requirements And Commitments
- FDA: Majority of Drug and Biological Product Makers Meeting Postmarketing Requirements and Commitments
- Cardiome Pharma Corp – Product Pipeline Review – Q4 2010
- A Look At Strong Product Pipelines And M And A in Biotech
- FDA: Majority of Drug and Biological Product Makers Meeting Postmarketing …