WASHINGTON – As a congressional conference committee knits together the Senate and House versions of a PDUFA package, pressure is mounting for it to darn a few holes – such as the lack of an effective track-and-trace system to reinforce the drug supply chain.

While the FDA, industry and advocacy groups agree that hole needs to be mended, they don't agree on how. Industry wants to start with lot-level tracking, while the FDA is holding out for unique identifiers that would enable tracking on the unit level. And now, a few lawmakers are pushing for an even more detailed fix.

A national track-and-trace system isn't enough, Sen. John Rockefeller (D-W.Va.) and Rep. Elijah Cummings (D-Md.) said in a letter this week to the conference committee, which includes the chairman and ranking member of the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions Committee.

While a unique identifier may show a drug is authentic, Rockefeller and Cummings said a national drug pedigree system is needed to show a drug has been handled by authorized, qualified distributors and dispensers. Such a pedigree would thwart counterfeiters, thieves and gray market manipulation.

The two lawmakers aren't the only ones looking at the supply chain hole. Premier also sent a letter to the conference committee this week, urging it to adopt language to establish a uniform, national traceability framework at the lot level.

The FDA was supposed to implement a track-and-trace system under the PDUFA package that will expire Sept. 30, but it never got done because the agency and industry couldn't come to terms. Neither the House nor Senate addressed the issue in their reauthorization bills.

The FDA has said no traceability framework is better than a substandard approach that could get locked into law, David Rosen, a partner and co-chair of the life sciences team at Foley & Lardner LLP, told BioWorld Today.

"Something needs to be done," he said, especially since California plans to implement a law in 2015 that requires full electronic track-and-trace capabilities that can determine the entire distribution history and the location, at any time, of every unit in the supply chain. With other states setting up their own systems, drugmakers are facing a patchwork of traceability requirements rather than one national system. (See BioWorld Today, March 12, 2012.)

To avoid an onerous approach, drugmakers need to come together in a concerted effort to develop a track-and-trace system that provides real value, Rosen said.

In another effort to sew up a hole in the PDUFA bills, a group of professional organizations and associations is asking the conference committee to give the FDA some enforcement tools if drugmakers fail to provide early notification of a shortage.

Civil monetary penalties would be the best mechanism to encourage early reporting, according to the group, which includes the American Hospital Association. But in lieu of that, the group would like the committee to adopt the House proposal under which the FDA could send publicly available letters to drugmakers who fail to report possible drug shortages early on.

The request echoes that of the American Society of Clinical Oncologists, which called last week for Congress to put some teeth into the drug shortage reporting requirement. (See BioWorld Today, June 5, 2012.)

The conference committee is still hopeful that the House and Senate bills can be reconciled and passed by July 4.

Myriad Could be Far-Reaching

As the deadline looms for filing briefs in the Federal Circuit redux of Association for Molecular Pathology v. Myriad Genetics, a group of 23 industrial, environmental, food and agricultural biotech companies is urging Department of Justice (DoJ) officials, as they draw up the government's brief, to consider the wide impact the case could have on the economy.

"We feel it is essential that it be understood that this case could potentially adversely impact ours and other industries whose activities are far removed from the clinical diagnostic testing context in which this case is commonly discussed," the group said in a letter this week to the U.S. attorney general and solicitor general.

The case, which the Supreme Court handed back to the U.S. Court of Appeals for the Federal Circuit for reconsideration in March, could invite a "broad reinterpretation of the judge-made exclusion from patentability for 'manifestations of nature' that would create significant uncertainty about the patentability of technologies unique" to a range of industries, the group said. (See BioWorld Today, March 27, 2012.)

The Association for Molecular Pathology (AMP) challenged Myriad Genetic Inc.'s composition claims on isolated DNA involving the BRCA1 and BRCA2 genes, used in diagnostics for breast and ovarian cancer, saying that isolated DNA is a product of nature and therefore not patentable. The solicitor general sided with AMP during the first oral arguments before the Federal Circuit. However, the appellate court ruled, in a split decision, that isolated DNA doesn't exist in nature, so it can be patented. (See BioWorld Today, April 5, 2011, Aug. 1, 2011, and Aug. 2, 2011.)

Noting that the Patent Office has granted patents on preparations of isolated DNA from plants, fungi, bacteria, and plant or livestock pathogens for the past 30 years, the industry group told DoJ that "subjecting such inventions to a new and uncertain patentability analysis . . . draws into question tens of thousands of issued U.S. patents and upsets longstanding, settled, investment-backed reliance interests."

NCATS Match-Making Program Expands

In only its second month, the National Center for Advancing Translational Sciences' (NCATS) pilot match-making program for failed drugs has more than doubled its pharma partners and the number of failed compounds available for a research date.

Abbott, Bristol-Myers Squibb Co., GlaxoSmithKline plc, Janssen Pharmaceutical Research & Development LLC and Sanofi SA have joined AstraZeneca plc, Eli Lilly and Co. and Pfizer Inc. in providing shelved compounds to the Therapeutics Discovery program, a crowdsourcing collaboration aimed at finding new uses for failed drugs. (See BioWorld Today, May 4, 2012.)

As a result, funding and molecular compound information is available now for 58 Phase I and Phase II candidates that failed the first time out or were de-prioritized by the sponsor. Preliminary information about the compounds – including mechanism of action, route of administration and use limitations based on safety and tolerability – is available on the NCATS website.

"By crowdsourcing compounds that already have cleared several key steps in the development process, including safety testing in humans, scientists nationwide have the opportunity to contribute their expertise to advancing these resources for new disease therapies," according to NCATS.

Researchers interested in hooking up with one of the compounds, and a share of $20 million in National Institutes of Health funding, must submit a pre-application by Aug. 14.