Whenever a new drug is disapproved, FDA issues a complete response letter (CRL) to the manufacturers citing all the reasons why it was rejected. These letters contain details of the applicant’s development program with specific deficiencies identified and potential solutions offered. The CRL becomes the roadmap for the applicant to satisfy FDA’s concerns and eventual approval. Due to the extremely confidential nature of this information, companies typically only disclose portions of the CRL relevant to their investors and the public. Due to the proprietary nature of the information, a given company has the right to not disclose any portions they believe to potentially hurt their competitive edge. In an article published this week in The BMJ, several FDAers challenge this right.
The authors of the article reviewed 61 CRLs issued between August 11, 2008 and June 27, 2013 (48 for NDAs and 13 for BLAs) to compare the proprietary information in those CRLs with the respective applicants’ public statements regarding the CRL. The authors attempt to highlight several critical pieces of information included in the CRLs regarding the reasons for rejection of the application and lack of such information in the applicant’s public disclosure. The articles raises serious questions about the right of the public to know why a drug is rejected and makes an altruistic claim that public disclosure of the complete CRL either voluntarily by the company or by changing the law to allow FDA to disclose it would somehow help drugs come to market faster. However, the article ignores the obvious loss of competitive edge to the company whose product got rejected and the importance of the CRL in allowing a given company to meet FDA’s specific concerns without providing tips to its competition about its development program.
The article also misdirects the real question of transparency; the information of such nature is not intended for the general public and patients as it seems to be indicating but for other companies who are developing similar therapies. It is intended to help other learn from someone’s mistakes. Is it fair for a company to make it’s competition better? What about the company’s obligations to its investors regarding protecting their assets? This is not an issue of greater transparency in FDA’s processes but rather of the importance of confidential interactions between FDA and companies.
The core element of these interactions is that companies be able to discuss all aspects of their product with FDA without fearing loss of confidentiality. Without a promise of great confidentiality, companies will not disclose key elements of their program to FDA due to business reasons severely hampering innovation and new drug development. The authors of the articles have their faith misplaced. FDA has been frequently accused of less transparency; and FDA in turn has blamed the industry of too much secrecy. This article is another effort by the FDA to move the heat away from itself. Impact of it will likely be marginal as neither of the parties can really change the dynamics of the process of FDA-Industry interactions.
Additional reading: http://goo.gl/n8PcuL
