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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Doc Bones who wrote (7347)	11/18/2002 12:04:03 PM
From: Biomaven	Respond to of 52153

Here's a fair comment on the FDA/drug company relationship: Learning to love the FDA Industry loves to blame the Food and Drug Administration for the slow pace of drug approval. But as in any relationship, both parties are at fault. by Jason Pontin November 15, 2002 The biotechnology industry loves to hate the Food and Drug Administration, blaming the slow pace of drug approval on what it sees as a bloated and uncaring government bureaucracy that regulates drugs to the detriment of patients, entrepreneurs, and investors (see "Biotech needs to slow down"). While many groups have an interest in successfully developing novel therapeutics, all the actual work is done by teams within pharmaceutical or biotechnology companies and their partners or vendors, interacting with regulatory review teams within the Food and Drug Administration. The interaction between these two teams defines the review and approval process: the relationship built over the decade or more that a drug is in development has major effects on the speed and efficiency with which a development program is completed. Thus, clear and effective communications between sponsor development teams and FDA review teams is a fundamental aspect of clinical development, a process that typically lasts 6 to 10 years and costs many hundreds of millions of dollars. Yet ineffective and incomplete communications are often responsible for substantial, but unnecessary, costs and delays. Of course, the development of a new drug typically has many false starts and delays, and some delays are anticipated by industry--but more often they are not. The companies typically blame these unexpected delays on the regulatory process itself, with the FDA acting as a convenient scapegoat. While it is difficult to measure how much wasted time in drug development is solely attributable to ineffective communication between the sponsors of new drug programs and their counterparts at the FDA, some experts say that as much 20 to 30 percent of total development time and cost could be saved if communications between sponsors and the FDA were clear, unambiguous, consistent, and timely. To me, the most obvious cause of poor communications are the misconceptions that biotechnology companies have about the FDA. Companies and FDA review teams have distinctly different objectives. Confusion about the role and constraints of the FDA often leads to ineffective and even counterproductive behavior on the part of inexperienced development teams. The FDA has in recent years worked diligently to refine its role as a regulator of the nation's new drugs, and as such the agency strives to be consistent, predictable, systematic, and as technically objective as possible. It aspires to be an impartial reviewer maintaining a level playing field for all sponsors. Many companies feel the FDA is susceptible to high-pressure sales tactics, but it is not a customer who can be convinced if the "pitch" is good enough. A common joke inside the FDA goes: "In God we trust--everyone else must show data." Ultimately, only data that objectively demonstrates adequate safety and efficacy counts with the FDA. While this level of caution may be exhausting to industry, it is both a necessary and inevitable result of the FDA's role as a regulatory agency. Companies may also misperceive the FDA as a taxpayer- funded consulting service. Of course, FDA staff does want to facilitate the development and approval of new therapeutics that will benefit patients, and they do provide structured guidance through written policies and direct interactions. However, the extent to which the FDA can provide such "value-added" services is sharply limited by a number of constraints, including the legal requirement of maintaining confidentiality among concurrent development programs, time pressures generated by the PDUFA (Prescription Drug User Fee Act) clock, and severe resource constraints that hinder it from fulfilling even its basic mandate. But while the FDA is not a partner, neither is it an adversary. The best thing that biotechnology could do would be to work more closely with the FDA--to respect its role and its concerns, and not fight its clear, socially mandated responsibilities. Nothing is more detrimental to the drug discovery process than attempting to outfox the FDA. Write to Jason Pontin. redherring.com