Washington Editor

WASHINGTON - Acting FDA Commissioner Andrew von Eschenbach might be one step closer to Senate approval following reports that the maker of the Plan B contraceptive product, Barr Pharmaceuticals Inc., agreed to file for over-the-counter status for women 18 and older.

That would appear to satisfy the agency's latest requirement for non-prescription sales of the so-called "morning after pill" and potentially pave the way for von Eschenbach's Senate approval. That process has been held up by a procedural block from Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.), who said they won't budge until the FDA makes a decision.

For his part, von Eschenbach recently stressed the agency's need to ensure that the product "can be used safely and effectively" if sold without a prescription. He discussed the issue earlier this month at a hearing of the Senate Health, Education, Labor and Pensions (HELP) Committee to discuss his nomination. (See BioWorld Today, Aug. 2, 2006.)

Following an FDA meeting since then, Barr said it decided to resubmit its Plan B application, this time tailored to the 18-and-older guidelines. Previously, the Woodcliff Lake, N.J.-based company had filed for over-the-counter sales to women 16 and older, following an original request for non-prescription sales to all women that dates to 2003.

The issue has become a well-documented albatross for von Eschenbach and his predecessor, Lester Crawford. The FDA's latest position was unveiled two weeks ago, just a day before von Eschenbach sat before the HELP Committee.

At the time, no vote was taken to send his nomination to the Senate floor, but the committee is expected to take up the matter next month. (See BioWorld Today, Aug. 1, 2006.)

The FDA has had a Senate-confirmed FDA commissioner for just 18 months in the past five years.

Kennedy-Enzi Bill Officially Introduced

Just before leaving town for this month's summer recess, Sens. Mike Enzi (R-Wyo.) and Edward Kennedy (D-Mass.) introduced a legislative proposal to strengthen the FDA's oversight of drugs after approval, the Enhancing Drug Safety and Innovation Act, in part by better addressing safety considerations before approval.

In a statement Enzi said the bill, which is labeled S. 3807, would "raise the bar" to ensure that safety is "not an afterthought, but an integral part of the process from the very beginning."

However, industry insiders aren't exactly enamored with the measure. Among other provisions, it would permit the FDA to impose a two-year ban on direct-to-consumer advertising for drugs with safety concerns, mandate risk evaluation and mitigation strategies in concert with any drug approval, create a new clinical trial registry, improve the agency's process for screening advisory committee members for financial conflicts of interest and establish a biomedical research group as a public-private partnership at the FDA to advance its Critical Path Initiative.

The bill has been expected for some time, and a draft was revealed last month. (See BioWorld Today, July 24, 2006.)

SOX Compliance Extension Proposed

The smallest of public biotech firms must be pleased to hear of the SEC's suggestion to extend the deadline for all smaller public companies to comply with Section 404 of the Sarbanes-Oxley Act.

The regulatory body proposed relief for such companies, which also are called non-accelerated filers, by pushing back initial compliance dates for management assessments of the company's internal control over financial reporting.

Such attestations would be moved from fiscal years ending on or after July 15, 2007, until fiscal years ending on or after Dec. 15, 2007.

Also, the date by which they must begin to comply with the requirement to provide an auditor's attestation on internal control in their annual reports would be extended to the first annual report for a fiscal year ending on or after Dec. 15, 2008. In addition, the SEC proposed a transition period for new public companies that would delay Section 404 compliance requirements to the date of a company's second annual report.

Non-accelerated filers comprise companies with market capitalizations under $75 million. The SEC said its proposal is intended to provide cost savings and efficiency opportunities as smaller public companies prepare to comply fully with Section 404's reporting requirements.