FDA, Transparency and Market Place Improvement

In June 2009 the Federal Drug and Administration (FDA) responded to President Obama’s commitment to promote transparency and openness in the government by launching an internal Transparency Initiative. The Initiative’s objective was to develop mechanisms that would promote the disclosure of information online to the public.

Toward this end, the U.S. FDA created a task force commissioned to communicate with the public and private and sectors, resulting in receipt of over 1500 suggestions with regard to methods of displaying information regarding FDA activities and decisions, designed to make information more readily available to the public.

It seems that the comments were well received by U.S. FDA, and that industry and the public can anticipate continued support of the Initiative.

Principal Deputy Commissioner Joshua Sharfstein stated, “We have heard from small and large companies about the need for the FDA to more clearly communicate about its standards and expectations – both for regulated products generally and for specific applications.”

Dr. Hamburg has supported the Transparency Initiative and advised, “In order to succeed, the FDA must clearly communicate standards and expectations to the industries it regulates.”

Based on the data collected from the public and private sectors, the FDA task force has made progress toward the Initiative’s goals in three phases:

Public Education
The task force created a page on the FDA website designed to make the nature and process of the agency clearer to the general public. The page, “FDA Basics,” was implemented January 2010, has been seen by more than 900,000 people thus far. The content of the page includes:

- Questions and Answers about the nature of FDA and the products they regulate

- Videos presenting common Agency activities

- Interviews with Agency officials, detailing the nature of specific agency centers and divisions

- Monthly Webinars on current topics

Coda Review: We at Coda strongly support any and every effort made to educate the general public on the relationship between the government and the industries of the private sector. An educated consumer has and always will, be the most effective and well protected consumer.

Read about other Phase 1 agency efforts to educate the Consumer in our Nov 2010 blog post:
http://blog.codacorpusa.com/2010/11/fda-transparency-and-consumer.html

Disclosure of Agency Efforts

As a result of the task force’s research and the feedback it obtained, in May 2010, a report was released. This report included 21 draft proposals discussing expanding the mechanisms designed to disclose agency information while continuing to support the confidentiality interests of the industry and consumers that are needed to protect trade secrets and patient privacy. The agency is in the process of determining which of these proposals will be implemented, and the possibility of a release of a significant amount of regulatory information is on the horizon.

One additional output from this phase is FDA-TRACK (www.fda.gov/fdatrack), launched in April 2010. This system was designed to present a monthly view of the current agency workload, and to measure the progress of more than 100 agency offices. The view was designed in typical dashboard fashion, presenting metrics on internal projects.

Coda Review: After reviewing the FDA-TRACK page, it is visible that not all centers are currently reporting (e.g., CDRH is not represented). It is clear that there is really no simple way to know which of the projects mentioned may be of interest or impact to any viewer’s particular organization. It is also clear that the metrics provided are about as meaningful as any metrics of projects with which you are not directly involved would be; it’s a little like sitting in someone else’s board meeting without a briefing.

We did find some interesting data that could be used to aid in ORA trend monitoring (e.g., pace and frequency of enforcement actions), but it took us a while to find it. Over time we’re sure users will become adept at locating information that is of interest and tracking that over time. However, overall we feel that the system could go farther to establish visibility that would be useful to industry, and that it would be of almost no use to the general public.

We look forward to seeing which proposals will be implemented.

Transparency and Industrial Cooperation
The third phase to be implemented (in less than a year’s time) is the launch of a new web page designed to provide a simple and easy to use reference center for the industries regulated by the Food, Drug and Cosmetic Act (Title 21).

http://www.fda.gov/ForIndustry/FDABasicsforIndustry/default.htm

Live in January 2011, it was created to help provide members of industry a clear and simple method of accessing process information, requirements, standards, and expectations. The hope is that this will decrease the burden of industry during their interactions with the agency, simplifying each point in every process.

After reviewing the page, it does appear that the design most frequently speaks to companies who do not have a depth of knowledge of these processes, or who are altogether new to this regulated environment. For instance, the following portals are prominently displayed:

1. How do I know if my product is regulated by the FDA?

2. What should I expect during an inspection?

3. I want to manufacture an FDA-regulated product. Where do I start?

As a member of industry, it was immediately apparent to us, that this type of information would not be required for the majority of companies functioning in this arena. However, it will be of use to start ups, or to any training group dealing with new employees.

In addition to the basics, the page also provides information that would be of use to the more established sectors of industry, including:

About FDA

This section lists the responsibilities of the FDA, directions to FDA Headquarters, leadership profiles, and organizational charts.

Guidance Documents

Guidances by product area and topic are listed, as well as explanations of how to submit comments on proposed regulations and petitions, withdrawn guidances, and possible topics for future guidance development.

Registration and Listing

This section contains the necessary links for registering facilities and products and how to update registrations.

Regulatory Process

This segment contains links that discuss the regulations of the FDA, how to submit questions and comments to FDA, links to laws and regulations, and links for how to submit comments on open dockets. There is also information about the Office of the Ombudsman. This is the agency’s central office for addressing complaints and assisting in resolving disputes between companies or individuals and FDA offices.

Product Application and Review Process

This section contains the necessary links for submitting applications and submissions, and user fee information.

Stay Informed

Methods for receiving updates and how to stay abreast of upcoming meetings and interactive media such as Twitter, Facebook, Podcasts and You Tube postings are included.

Search Databases

This section contains a list of databases for each industry group such as Adverse Event Reporting System (AERS), Drugs@FDA (list of the approved drugs), Medical Device Database, and more.

Insight Categories

FDA, Transparency and Market Place Improvement

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