A Medical Device Daily

The FDA said it is amending its medical device reporting regulations to remove a requirement for baseline reports that the agency deems no longer necessary.

Currently, manufacturers provide baseline reports to FDA that include the FDA product code and the premarket approval or premarket notification number. Because most of the information in these baseline reports is also submitted to FDA in individual adverse event reports, FDA said it is removing the requirement for baseline reports. The removal of this requirement will eliminate unnecessary duplication and reduce the manufacturer's reporting burden, the agency said.

FDA is amending the regulation in accordance with its direct final rule procedures. The rule is expected to become effective on Oct. 27.

NIH to make changes to peer review system

NIH Director Elias Zerhouni, MD, reported that his agency will make critical changes to enhance and improve its peer review system.

An important component of the new plan, the agency said is an increased commitment to "investigator-initiated high-risk, high-impact research to prevent a slowdown of transformative research, despite difficult budgetary times."

"The scientific community became truly engaged in this comprehensive effort to figure out how to make peer review work better for both the reviewers and the applicants," Zerhouni said. "The results of this collective effort are concrete solutions that will maximize flexibility, remove any unnecessary burden, stimulate new innovation, and promote transformative research."

The Implementation Plan Report consists of four main priorities and highlights include:

Priority 1 — Engage the Best Reviewers: Increase flexibility of service, formally acknowledge reviewer efforts, further compensate time and effort, and enhance and standardize training

Priority 2 — Improve Quality and Transparency of Reviews: Shorten and redesign applications to highlight impact and to allow alignment of the application, review and summary statement with five explicit review criteria, and modify the rating system

Priority 3 — Ensure Balanced and Fair Reviews Across Scientific Fields and Career Stages

Support a minimum number of early stage investigators and investigators new to NIH, and emphasize retrospective accomplishments of experienced investigators

Encourage and expand the Transformative Research Pathway

Create a new investigator-initiated Transformative R01 Award program funded within the NIH Roadmap with an intended commitment of a minimum of $250 million over five years

Continue the commitment of — and possibly expand the use of — the Pioneer, EUREKA, and New Innovator Awards. NIH will invest at least $750 million in these three programs over the next 5 years.

Reduce the burden of multiple rounds of resubmission for the same application, especially for highly meritorious applications

Priority 4 — Develop a Permanent Process for Continuous Review of Peer Review

"As we contemplated possible changes, we were guided by several fundamental principles. First, while improving the system, do no harm. That is, ensure that any changes to the peer review system bring significant value and outweigh costs," said Zerhouni. "Second, continue to maximize the freedom of scientists to pursue high-risk, high-impact research. Moreover, we want to cultivate a sense that we continuously re-evaluate the peer review system to ensure that it is the best that it can be."

FDA says baby bottles containing BPA are safe

Plastic baby bottles containing bisphenal A (BPA) a chemical used to make polycarbonate plastics are safe, an FDA official told a House subcommittee last week.

In April the FDA formed an agency-wide BPA Task Force to review current research and new information on BPA after studies in lab rats linked the chemical to brain and reproductive problems, as well as breast and prostate cancer.

Concerns about BPA have been brewing since a draft brief by the National Toxicology Program (NTP) of the National Institute of Environmental Health Services, a component of the National Institutes of Health, found "some concern for neural and behavioral effects in fetuses, infants and children at current human exposures." The NTP also said in April that it has "some concern" for BPA exposure in these populations based on effects in the prostate gland, mammary gland and an early onset of puberty in females (Medical Device Daily, April 24, 2008).

According to an Associated Press report, Norris Alderson, PhD, the FDA's associate commissioner for science, told a House subcommittee that there is no reason to recommend consumers stop using products with BPA. Small amounts of BPA can be released as plastics break down, he said, but the level of exposure is safe.

Some studies had reported higher release levels than projected by the agency, but many of those studies were conducted under unrealistic conditions, Alderson said.

CMS publishes new hospice CoPs

For the first time since the Medicare Hospice Conditions of Participation were created in 1983, the regulations for Medicare-certified hospice providers issued by the Centers for Medicare and Medicaid Services have been significantly revised. The new Conditions of Participation (CoPs) have a strong focus on patient-centered care that emphasizes quality assessment and performance improvement and patient outcomes.

The National Hospice and Palliative Care Organization (Alexandria, Virginia) applauded publication of the new CoPs.

Medicare certified hospices have 180 days in which to become compliant with the new regulations that go into effect on Dec. 2, 2008.

The new CoPs include explicit language on patient rights that had not existed under the previous regulations. Specifically, patients who choose hospice or palliative care over curative treatment are entitled to such things as participation in their treatment plan; the right to effective pain management, the right to refuse treatment and the right to choose his or her own physician.