FDA suggests supplement firms keep internal records of adverse event data with the same coding system for medical conditions and symptoms that the agency uses.

FDA Center for Food Safety and Applied Nutrition executives, in a December meeting with industry stakeholders, proposed firms use the international Medical Dictionary for Regulatory Activities for coding AERs.

CFSAN officials clarified following the meeting that supplement firms should not include MedDRA codes in the reports they are required to submit to FDA. The agency wants those reports to reflect language consumers use, FDA says.

While the guidance for supplement AERs says reports submitted to FDA should not use MedDRA terminology, agency officials say using the codes in firms' internal records will help if later analysis of those records is needed.

MedDRA provides technical medical codes, or terms, to classify medical conditions and symptoms in reports. If firms record adverse events internally with the same codes FDA uses, the agency could more efficiently compare records after identifying a safety signal.

More Efficient AE Data Comparison

Andrew Shao, the Council for Responsible Nutrition's VP of scientific and regulatory affairs, said the meeting was the first time he had heard FDA request that industry use a standardized system for notating AE data. Using MedDRA "makes the data mining much easier than having lots of different ways to describe" an event, Shao said.

The Maintenance and Support Services Organization says it designed MedDRA "for the specific use of sharing regulatory information and clinical safety data for human medical products worldwide."

Using "a standard set of MedDRA terms allows health authorities and the biopharmaceutical industry to more readily exchange and analyze data related to the safe use of medical products," the organization's Web site says.

Internal records with MedDRA notation would enhance FDA's monitoring system, agency officials explained in the meeting with industry executives. For instance, MedDRA codes may have helped FDA officials when they began inspecting Iovate Health Science's AERs for Hydroxycut weight-loss supplement products after detecting a possible link to liver problems in reports that had been submitted to the agency (¹ Also see "Hydroxycut Recall Eyed As Trigger For Closer Look At Supplement AERs" - Pink Sheet, 18 May, 2009.).

CFSAN execs met at their headquarters in College Park, Md., with supplement industry stakeholders in December to explain the agency's process in calling for a recall of 14 Hydroxycut products (see ² Also see "FDA Says Supplement AERs Will Be Subject To Lower Threshold Before Action" - Pink Sheet, 11 January, 2010. ).

Like Consumers, Firms Don't Speak In Codes

Rick Kingston, president of scientific and regulatory affairs for Safety Call International, noted consumers generally don't use MedDRA's "very technical medical terms." Likewise, supplement firms may not be experienced in "translating consumers' descriptions of their effects into fairly technical terminology," he said.

For example, he said when a consumer tells a firm about "this tingling sensation throughout my arms and legs," MedDRA terminology could suggest a condition of peripheral neuropathy.

"Well, people don't call up and say, 'Hi, I've got peripheral neuropathy.' So what you've got to do is first of all determine whether or not the person is adequately describing over the phone what their effects are, and then those have got to be translated into terms that are fairly technical."

However, standard coding for medical conditions or symptoms would improve the supplement AER database, Kingston said. "It is going to be helpful for the company to know how their adverse events are actually being depicted ultimately in the database."

United Natural Products Alliance Executive Director Loren Israelsen pointed out using MedDRA was suggested but is not required. "We need to understand really well the pros and cons of the system," he said.

According to the MedDRA Web site, subscription rates for the service are based on firms' revenues: $190 for firms with annual revenues below $1 million, $804 for between $1 million and $10 million, $5,529 for $10 million to $500 million, and higher for larger amounts. Regulatory agencies and nonprofits are not subject to the fees.

Kingston pointed out the costs do not "include the time and effort of staff with medical training" to do the coding.

- Katie Stevenson ( ³ k.stevenson@elsevier.com )

FDA Suggests Supplement Firms Use MedDRA Internally For AER Data

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