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The new FDA Amendments Act of 2007 includes provisions that will dramatically expand public access to information on drug and medical device clinical trials.

The new rules require the National Institutes of Health (NIH) to create a searchable database containing descriptive information about clinical trials available to the public over the Internet. The new rules also require FDA to promulgate new regulations regarding how information is to be supplied to NIH for inclusion in the database.

These rules significantly increase the information pharmaceutical and medical device companies must make available to the public.

Which Studies Must Be Included?

Sponsors must provide information for controlled clinical trials that support efficacy claims as well as controlled clinical trials conducted after the drug or device involved is approved. Phase I and proof of concept trials are exempted. The statute also requires sponsors to register information about ongoing trials for drugs and devices that have not yet received FDA approval.

What Information Must Be Provided?

The database must include, among other things:

(i) the title of the trial in lay terms;
(ii) the primary purpose of the trial in lay terms;
(iii) eligibility criteria for study subjects;
(iv) a description of the disease or condition being studied;
(v) a simple description of the study design; and
(vi) for ongoing trials, the anticipated completion dates.

NIH must also include in the database a glossary to help the public understand “technical terms related to the results of clinical trials.”

In addition, FDA and NIH must:

• Provide links to Medline publications or other information “focused on the results of” clinical trials;
• Post FDA summaries of any applicable advisory committee proceedings;
• Post FDA public advisories regarding any drug or device in the database.

When Must the Information Be Provided?

The new rules requires sponsors to submit to NIH summary information on all qualifying trials by September 2008. This summary information must include demographic information, information on the primary and secondary outcomes, a contact person for information about the trial, and a disclosure as to whether agreements exist between sponsors and third parties that limits the manner in which results may be used in public fora.

Thereafter, sponsors must provide information to NIH for inclusion in the database within a year of completing the study, or 30 days after FDA approves the product, whichever is earlier.

Must FDA Issue Any New Regulations?

Within three years, FDA must promulgate regulations to expand the information in the database to include a summary in lay terms of the trial and its results and the full study protocol. The new regulations must also consider whether a standard format for submission is appropriate. A public meeting on these issues must be held within 18 months.

Within 18 months, FDA must promulgate new regulations establishing “the best method for including in the registry and results data bank appropriate results information on serious adverse events and frequent adverse events” for pharmaceuticals. If FDA does not promulgate such regulations, the sponsors will be required to provide a table listing serious adverse events by organ system as well as a table of adverse events “that exceed a frequency of 5 percent.”

Does the Legislation Impose Any Other Requirements?

The legislation contains several other provisions regarding the clinical trials database:

• The database must be searchable by keyword as well as “safety issue”;
• NIH must post the information within 30 days of receiving it;
• FDA may waive a sponsor’s obligation to post certain clinical trial results upon request;
• FDA may also require sponsors to provide information on trials that do not otherwise meet the criteria, if FDA determines that the public health requires it;
• The legislation imposes civil penalties of up to $10,000 per violation on any sponsor that submits false or misleading information to the database. The penalty increases by $10,000 per day for each day that the false or misleading information is not corrected; and
• The legislation specifically preempts states or state agencies from requiring sponsors to include information in any similar database.