Medical Device Daily Washington Editor

Publication rights to peer-reviewed articles based on research that is funded in whole or in part by Uncle Sam have been a flashpoint in the publishing industry for several years, and the recently passed federal government funding bill finally puts into play a requirement that such articles be made available to the taxpayer free of cost.

The year-ending spending bill, dubbed the Consolidated Appropriations Act of 2007 (H.R. 2764), directs the National Institutes of Health to publish such articles online 12 months after the date of publication in the journal in which the article first appeared.

NIH’s existing policy, known as the Public Access Policy, was a voluntary measure put in place in 2005 that had essentially the same effect for publishers who were willing to go along with the idea. However, the new law makes such access mandatory, and the full text of any affected articles have to be made available through PubMed, the online archive run by the National Library of Medicine.

According to a report published at the web site for the Alliance for Taxpayer Access (Washington), Harold Varmus, PhD, formerly the NIH director and now the president of the Memorial Sloan-Kettering Cancer Center (New York), said in a statement that the more rapid access to knowledge “is key to the rapid advancement of science.” Varmus added “[t]he tremendous benefits of broad, unfettered access to information are already clear from the Human Genome Project” and that “even with a one-year delay, to the full text of research articles supported by funds from all institutes at the NIH will increase those benefits dramatically.”

Heather Joseph, the executive director at the Scholarly Publishing and Academic Resources Coalition (Washington) said in the prepared statement that with the bill, “Congress has just unlocked the taxpayers’ $29 billion investment in NIH.” Joseph also said that the new policy “will directly improve the sharing of scientific findings, the pace of medical advances, and the rate of return on benefits to the taxpayer.”

Uptick in FDA budget slight

The Consolidated Appropriations Act of 2007 (CAA) is not necessarily a sign of greater comity inside the Beltway, but at least Congress and the White House are finally forging agreements on some spending. On the other hand, while this bill includes an increase in FDA funding of $79 million over the Bush administration’s proposed budget for the agency, not all observers are impressed.

The bill will deliver $1.73 billion to FDA for FY08, which is $145 million above the agency’s FY07 allocation. The FDA Amendments Act of 2007, which President Bush signed into law Sept. 20, adds another $287 million in device user fees for product reviews between fiscal years 2008 and 2012. Precisely how FDA will allocate the additional funding provided by the CAA is not clear.

Former FDA commissioner and current senior advisor to the Coalition for a Stronger FDA (Washington) Bill Hubbard told Medical Device Daily in an e-mail that “we are gratified that the FDA budget was increased in a year in which budget increases were difficult to come by for many domestic agencies, following several years in which the agency’s budget has been cut” when adjusted for inflation. However, Hubbard added “given the major problems that have been identified regarding FDA’s ability to carry out its mission, it is evident that the agency will need large increases in the future if it is to be successful.”

Two firms get holiday warnings

The holidays are no time to slack off in the device industry, and FDA seemed to be following suit, dishing out warning letters to a pair of device makers at the beginning of the month.

The Dec. 7 warning to Spinal USA (Flowood, Mississippi) indicated that FDA gave the firm a chance to deal with the inspectional findings, saying that the inspection took place in late May and early June. Nonetheless, FDA cited Spinal for failure to update its in-house specifications for several spinal products the company had outsourced to a contractor. The warning letter likewise cited Spinal for validation failures in connection with the problem, which was associated with the company’s cement restrictor system and the vertebral body replacement system.

The warning letter also noted that Spinal was in possession of “two different design plans for the anterior cervical plate assembly, one used by the contract manufacturer and one on site at the specification developer.”

As might be expected, device master records (DMRs) were similarly out of date. The warning letter said that Spinal, despite a requirement to maintain updated DMRs on all iterations of a device, had none for the design in use by the contractor. FDA said that the company also lacked “information on the dates of manufacture, quantity manufactured, quantity released for distribution, acceptance records, primary identification labeling for each production unit, and device identification and control number(s) used for the devices you manufacture.”

The Dec. 3 warning addressed to Pacific Consolidated (Riverside, California) maker of portable air separation devices, also noted problems with design controls.

According to FDA, the company’s “document change control procedure does not ensure that design changes are verified, and lacks criteria to determine whether a design change required verification or validation before its implementation.” This citation was apparently a systemic problem inasmuch as the warning letter cited no specific product line in connection with the citation.

A problem cropped up in connection with Pacific’s Expeditionary Deployable Oxygen Concentration system (EDOC), which is listed at the web site of the United States Air Force as a product for medical care at forward military bases. According to FDA, the design “was not validated using production units under actual or simulated use conditions.” The agency also alleged “your design history file for the EDOCS-120B contains multiple instances of conflicting requirements.”