My New Year’s wish for genomics is for the Bush Administration to appoint a new commissioner for the US Food and Drug Administration. The current headless agency is doing considerable damage to the genomics industry’s long-term financial prospects—and hurting hundreds of thousands of patients in the process—by needlessly delaying approval of new drugs and biologics for nothing more than additional paperwork requirements.
This FDA is afraid to take a stance even on the most important and demonstrably effective drugs without a Commissioner to take the political heat. Afraid of the media and so-called consumer groups like Public Citizen that would have screamed to have aspirin banned if had been submitted for approval today, the FDA bureaucrats are simply hiding behind the higher and higher mounds of paper they order up.
In an effort to avoid any criticism, they are not only asking companies to dot every “i” and cross every “t,” they're asking them to invent new alphabets.
It’s bad enough that the FDA has the power to reject drugs because it believes it may not be as effective as other similar drugs currently on the market. The agency has been wrong on that score in the past. But now it is rejecting and delaying drugs that have shown significant declines in mortality.
A case in point: Eli Lilly’s genetically engineered sepsis drug, Xigris. Xigris saved the lives of people from lethal infections where no other drug could. Its efficacy was documented, and yet the FDA committee deadlocked 10-10 on the drug’s effectiveness! Lilly submitted the same data in a different way and received approval months later, costing the company millions and likely costing many people their lives.
Now the latest victim of FDA timidity is ImClone’s genomics-derived cancer drug, C225. The ImClone drug received an approvable letter for its efficacy in treating colorectal cancer, and soon cancer patients and their doctors were eager to get a hold of it for many oncologic applications.
ImClone had hoped to launch the drug, projected to be a blockbuster, as early as next May. But along came the FDA and rejected the drug. Why? It needed more data. “We didn't understand the importance of making sure we documented the pathway of how the doctors reached their conclusions,” said Harlan Waksal, ImClone's chief operating officer. “We felt the conclusions would be enough. But clearly the documentation and the pathway are equally critical.”
The problem isn’t you, Harlan. After all, the FDA has approved other cancer drugs with a lot less documentation. Now ImClone's drug will not be available for another year.
We know what it means for patients. What does this mean for genomics? Several things. First, it means that biotech partners will have to burn more money on paperwork instead of R&D. Second, it means that genomics companies with plans to get into the drug-development business must realize that investors are now going to ask if the company has the time and money to satisfy the FDA’s new interest in bean-counting and bookkeeping.
Several companies beside ImClone, including Janssen, GlaxoSmithKline, Parke-Davis, Introgen, and Millennium are conducting extensive genomics-based oncology research. This innovative and important area of research just got more expensive and discouraging. It can all change, though, if the Bush Administration appoints an FDA commissioner with a commitment to medical progress and the vision to understand that economic and scientific costs of regulation come at the expense not only of the companies they review, but also of the public they are supposed to serve.
Robert Goldberg is a senior fellow at the Manhattan Institute and a senior research fellow at the Ethics and Public Policy Center. You can e-mail him at [email protected].
Trendspotter is a weekly column that focuses on how trends in politics, patent law, and the US and European markets will affect the genomics industry. The column appears every Friday.
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