In a letter dated May 27, 2015, the House Committee on Energy and Commerce ("Committee") informed the FDA that it is examining the FDA's use and publication of untitled letters, questioning whether the policies and practices associated with the letters "are consistently fair, effective, and efficient in gaining compliance."

 

The Committee noted that each FDA center has its own policy on which letters get posted:

• CDER posts untitled letters related to advertising and promotion
• CFSAN posts untitled letters related to violations from manufacturing controls or labeling that do not meet the threshold for a warning letter
• CVM posts all untitled letters issued by the headquarters office, but not those issued by the field offices

 

The Committee went on to criticize the issuance and posting of untitled letters.  As an example, the Committee described an FDA inspection of a facility of a publicly traded company that resulted in a No Action Indicated (NAI) classification and no issuance of an FDA Form 483.  More than a year later, the company received an untitled letter from the FDA indicating that a violation was found based on the inspection.  Three business days after sending the untitled letter, FDA released the letters on its website, and the company's stock dropped 36% in value in a single day.  A shareholder lawsuit was filed against the company related to the untitled letter.  The Committee noted that the FDA posted the letter during a business day and before the company was able to engage with the FDA to address its concerns, which is seemingly contrary to the FDA's aim of limiting the economic impact of an untitled letter.

 

The Committee also questioned the inconsistencies in publicizing the untitled letters, noting that some are posted quickly on the FDA's website, while others only become publicly available after multiple FOIA requests.

 

The Committee asked the FDA to respond by June 10 to nine questions about its untitled letters process.  Protocol Link will cover FDA's response if, and when, it is made public.

Would you attend a friendly lunch meeting with your local FDA district office where you could meet the officers to learn about what they do and where they see the Agency heading in the future? Two members of the Protocol Link staff (Laura Spiegelhoff and myself) did so on May 19, 2015 where we attended a networking meeting with the Minneapolis District of the FDA sponsored by the Wisconsin Chapter of RAPS.

 

Michael Dutcher, DVM, District Director of the Minneapolis District of the FDA, who formerly worked in the USDA near Madison, WI, gave an overview of the FDA in general and specifically the responsibilities of the Minneapolis District Office. The Minneapolis District is part of FDA's Central Region which is the largest in the FDA as far as number of establishments, and spans the US from the Dakotas to Kentucky to New Jersey. The Minneapolis District is responsible for WI, MN, ND and SD, employs over 100 people in all 4 states and is responsible for almost 12,000 regulated establishments. Most of the industry that the Minneapolis District regulates is food and veterinary, including some very large food corporations. Interestingly, WI and MN have a growing presence in the medical device industry and are home to some of the largest and most well-known medical device companies in the world. The District is also home to a few, but innovative, blood banking and blood products companies.

 

The Minneapolis District Office's Investigations Branch, headed by Captain Gregory W. Smith, like all FDA district offices, has to be versatile to be able to ensure patient and food safety. In this meeting, it was highlighted that one recent expectation in the FDA is towards specialization - investigators are now expected to be experts in one commodity, such as medical devices, rather than being generalists. The districts and the FDA national office do not have a final strategy yet on how specialization will be achieved. In addition, the number of required investigations of foreign companies has been steadily increasing which is placing a burden on the Districts. The FDA is exploring some innovative avenues to reduce this burden, including possible acceptance of inspections by ex-US regulatory authorities in certain countries, such as the UK and Canada. Stay tuned!

 

The District Compliance Branch, led by Commander Chris van Twuyver, has also been very busy. In 2014, the District issued 23 Warning Letters, 9 Untitled Letters, and held 4 Regulatory Meetings. In addition, the Compliance Branch is responsible for recalls and imports. The numbers of imports and therefore related import actions have been steadily increasing in the District and in the US overall.

 

The final presentation, given by Dr. Dutcher, outlined the FDA's 2015 priorities and challenges. One of the challenges, and arguably the most surprising comment during the meeting, was that due to the FDA not moving fast enough to implement the Food Safety Modernization Act (FSMA), the FDA itself is now under a Consent Decree! The FDA now has defined phases with associated timing it must meet to implement FSMA.

 

Another challenge internal to the FDA stems from a directive issued by former FDA Commissioner Margaret Hamburg in 2012 for FDA program alignment, including training, planning processes and performance metrics, new compliance and enforcement strategies, lab optimization and specialization, and specialization across inspection and compliance (previously mentioned in this article). Program alignment is projected to be completed in 2017 and the outcomes could have ramifications for industry.

 

Globalization is also a big challenge for the FDA. Some interesting statistics given include:

• There are 300,000 establishments in 150 countries that supply regulated goods to the US.

• Fifteen to twenty percent of US foods consumed are from ex-US (from 228 countries).

• The US imports 80% of APIs and 40% of finished drugs and sources drugs in 150 countries.

 

In order to meet this challenge, the FDA is implementing some new strategies, including risk-based screening, intelligence gathering and risk analytics, allocation of resources based on defined risk, creation of dedicated foreign inspection cadres (drugs, foods, devices), international harmonization efforts (eg. IMDRF), engagement of foreign offices, and increased number of foreign inspections.

 

We appreciate that the Wisconsin Chapter of RAPS provided this unique opportunity to interact closely with members of the FDA and hear their perspective about what the future holds.   This will be a challenging and interesting time for industry and the FDA. We at Protocol Link are looking forward to FDA meeting their goals and are ready to help industry meet any challenges you may face as a result.