Washington Editor

WASHINGTON – Things should be a little quieter at the FDA this week as new safety reporting requirements go into effect to reduce the "noise" from the overreporting of individual serious adverse events in clinical trials.

Sponsors of investigational new drugs (INDs) and biologics will be picking up the tab for that golden silence as they now have to ramp up their analysis of which serious adverse events should be reported to the FDA in an expedited manner, filtering out those that likely were not caused by the drug being studied.

"The regulations appear to impose a greater burden on sponsors to determine when an adverse event is reportable," said Nisha Shah, an attorney with Hyman, Phelps & McNamara PC. As a result, sponsors will have to do more analysis of individual events.

In the long run, the FDA anticipates the final rule will make the process of getting a drug to market more efficient as it will reduce the number of uninformative individual safety reports, so-called "noise," the agency must review.

For instance, the FDA doesn't want individual reports about serious adverse experiences that were likely a result of the underlying disease, commonly occur in the study population or were study endpoints.

"These types of reports are generally uninformative when reported as single events . . . and, therefore, do not meaningfully contribute to the developing safety profile of an investigational drug," according to a draft guidance that was released, along with the final rule, last September. (See BioWorld Today, Oct. 4, 2010.)

On the other hand, sponsors are now required to rapidly report:

• findings from clinical or epidemiological studies that suggest a significant risk;

• serious, suspected adverse reactions that occur more frequently than anticipated;

• serious adverse events from bioavailability and bioequivalence studies that are exempt from IND requirements.

By ensuring that the information in an IND safety report is relevant and useful, the revisions are expected to improve the FDA's ability to review critical safety information, the agency said. The new requirements also are designed to harmonize safety reporting internationally and improve the safety monitoring of drugs and biologics.

Sponsors shouldn't have to make major changes to comply with the new requirements, the FDA said, but they should review ongoing trials to determine if any changes are necessary to meet the new rule.

Since certain adverse events must now be reported in the aggregate rather than as individual cases, sponsors will need a systematic approach to safety surveillance that includes a process for evaluating accumulating safety data.

Another increased burden for sponsors is that they will have to be more diligent about promptly reviewing all information relevant to the safety of the investigational drug.

The FDA expanded the sources sponsors should check to include "any clinical or epidemiological investigations, animal or in vitro studies, reports in the scientific literature, and unpublished scientific papers, as well as reports from foreign regulatory authorities and reports of foreign commercial marketing experience for drugs that are not marketed in the United States."

The agency advised sponsors to conduct literature searches at least annually to find new safety information for reporting purposes.

Although these requirements apply only to premarket safety reporting, the FDA is working on a rule for postmarket reporting.

Possible Fast Review of Health Care Law

The U.S. Supreme Court will consider a request April 15 to decide the constitutionality of the new health care law without waiting for a federal appeals court to weigh in.

If the Supreme Court grants the state of Virginia's request to bypass the U.S. Circuit Court of Appeals for the Fourth Circuit, it could hear Virginia v. Sebelius later next month or schedule it for the next term, which begins Oct. 3. The case, along with another challenge to the law, is set for May 10 in the Fourth Circuit. (See BioWorld Today, March 14, 2011.)

FTC Drops Appeal for LabCorp Injunction

The Federal Trade Commission (FTC) is backing off its efforts to enjoin Laboratory Corp. of America's $57.5 million acquisition of Westcliff Medical Laboratories, of Santa Ana, Calif. The FTC withdrew its appeal last week to a federal district court's rejection of a preliminary injunction to keep LabCorp, of Burlington, N.C., from integrating the Westcliff assets.

The agency said it also has withdrawn the matter from administrative adjudication – a step that stops the trial proceedings, but does not conclude the case. The FTC challenged LabCorp's acquisition of the rival clinical laboratory testing company in December, alleging it would harm competition. (See BioWorld Today, Feb. 25, 2011.)