Increasing patient involvement in FDA application reviews also may lead to the agency quickening its screening for conflicts of interest.

Reforms requiring an increase in the patient voice at FDA as well as loosening conflict of interest regulations to include more experts on advisory committees were part of the user fee reauthorization statute enacted earlier this year.

As the agency begins its implementation efforts, it is considering ideas to speed up its process for determining whether potential experts have problematic conflicts of interest that would exclude them from participation on an advisory committee or another capacity.

One of the ideas includes creating a group of pre-approved patient representatives that could fill committee slots or participate in formal meetings with sponsors on shorter notice than currently possible.

Richard Klein, a public health specialist in the Office of the Commissioner’s Office of Special Health Issues, said the agency sometimes cannot clear potential patient representatives in time to participate in an advisory committee or other meeting.

Candidates fill out long forms and undergo two screenings. The first ensures the person is not too conflicted to enter the patient representative program. Another confirms there are no conflicts related to the meeting topic.

“What we’re trying to do is figure out: Can we get a separate pool of people who we know prospectively have minimal conflicts of interest and when it comes to that secondary screening we’d be able to get them through much more quickly,” Klein said during a recent conference on rare diseases.

Screening can last several months just to be qualified as a patient representative. Another six to eight weeks is necessary for screening on a particular matter. That limits the potential for allowing patient participation in type A, B or C formal meetings, because they must be held at most 30, 60 or 75 days (about four to 11 weeks) after the request is made, respectively.

Divisions In FDA’s Pilot Program To Increase Patient Involvement

CDER: oncology, gastroenterology and anti-virals
CDRH: Office of In-Vitro Diagnostic Device Evaluation and Safety and possibly the Division of Cardiovascular Devices
CBER: Vaccine-related offices and divisions, but also potentially product-specific, such as with controversial or breakthrough products

If successful, the secondary pool could benefit rare disease patients, as well as sponsors, who spent a lot of time during the user fee reauthorization process lobbying to make more experts available for advisory committees through conflict of interest reform.

Patient groups argued that the existing rules were in some cases barring most of the small number of available experts from participating in advisory committee meetings Also see "PDUFA Word Association: Consumer Advocates Complain About Lack Of "Safety" In Commitment Letter" - Pink Sheet, 31 October, 2011..

Consumer groups said there were plenty of available experts without conflicts and that recruiting needed to improve Also see "Conflict Of Interest Reform: With FDA Undecided, Consumer Groups Give Their Pitch" - Pink Sheet, 9 January, 2012..

Lawmakers sided with the patient groups, removing the caps on financial conflict of interest waivers, although FDA’s practices were not expected to change dramatically ([A#00120716009]).

Review Divisions Pilot Patient Involvement

The user fee reauthorization legislation also instructs FDA to increase patient involvement in drug development decisions. The agency should bring more patients into meetings between FDA and sponsors and as consultants to review divisions, the law says.

Patients can participate in “appropriate agency meetings,” according to the statute, but the agency has not yet decided how that will be defined.

“We think that will change or be different from one center to the other,” Klein said.

Klein also said it is unclear how early in the development process a patient representative will participate or how exactly they will contribute.

Pilot programs already are in place to gather more patient views within certain review divisions, Klein said.

Within six months, the participating divisions are expected to be receiving patient perspectives at sponsor meetings. In about a year, the Office of Special Health Issues will determine how best to implement the program across all divisions.

The oncology, gastroenterology and anti-virals divisions in the Center for Drug Evaluation and Research and Office of In-Vitro Diagnostic Device Evaluation and Safety and/or Division of Cardiovascular Devices in the Center for Devices and Radiological Health have pilots in place. Certain product reviews in the Center for Biologics Evaluation and Research, such as controversial or breakthrough vaccines, also could gain more patient representation.

Disease-Specific Meetings Generated Dissention Among Patients

FDA also is required in its agreement with industry to continue the prescription drug user fee program to conduct 20 disease-specific meetings with patients to help reviewers better understand risk tolerance and other issues that could affect application decisions.

The agency created a firestorm in the patient community when it released a preliminary list of 39 candidate topics for the meetings, which are planned over the next five years.

Several groups were angry their disease was not on the list and FDA had to clarify that the conditions selected would not be its only priorities ([A#14121019008]).

At a public hearing to gain opinions on how the meetings should be structured, advocates said the agency should focus individual meetings on diseases with similar characteristics, so more could be included.

FDA is worried that broadening the focus of the meetings may not solicit the type of specific information reviewers need about a disease ([A#00121029015]).

FDA Conflict Of Interest Screening Could Get Streamlined As Patient Involvement Increases

More from United States

More from North America