FDA’s Final Pharmacology Labeling Guidance Will Increase Prominence of Genetic Information In Drug Labels
Hoping to highlight genetic information more prominently for prescribing physicians, the US Food and Drug Administration plans to issue a guidance that outlines a new format for the clinical pharmacology section of a drug’s label, an FDA official said this week.
The agency is poised to release draft guidelines for the “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format” Lawrence Lesko, director of FDA’s Office of Clinical Pharmacology and Biopharmaceutics, said at a pharmacogenetics conference held by the American College of Clinical Pharmacology in Washington, DC, this week. The agency didn’t say the exact date it plans to release the document.
The format for new drug labels will include a pharmacogenomics section and will move up pertinent genetic information to a box at the top of the label along with other information physicians should be immediately aware of prior to prescribing a drug.
With a pharmacogenomics section in new labels, the FDA is “planning ahead,” Lesko said. “We’ll at least be able to begin to establish a beachhead in the label that is specifically intended for pharmacogenomic information that comes out of drug development or that comes out of post-marketing studies.
“If this information is important enough, in the new FDA label, it moves to the top of the label where the important stuff is for prescribers,” Lesko said. “That’s a continuation of our attempt to get patients and prescribers to focus on what I feel is very important information.”
The agency’s regulatory actions have recently reflected a pharmacogenomics focus. In its response to the Institute of Medicines’ report on the “Future of Drug Safety,” the agency mentioned pharmacogenomics as a tool to “strengthen the science” that supports the drug-safety system.
“The thread that connects all of the stuff on drug safety are genetic factors, setting a strategic agenda for the FDA to continue to push this agenda forward,” Lesko said.
Historically, genomics information was included in product labeling as pharmacokinetic and pharmacodynamic data and was categorized under the pharmacology section, which was logistically situated in the bowels of lengthy and text-heavy product labels.
“If you took each section of a label and ranked what physicians read first or most, clinical pharmacology is not at the top of the list. I think it’s actually at the bottom of the list, right before [the] ‘overdose’ and ‘toxicology’ information,” Lesko said. He said the agency wants to “improve over time is where [clinically relevant genetic] information appears in the label.”
In the new drug labels, FDA has improved the prominence of relevant genetic data by “pulling out all the clinical pharmacology information in the old labels and moving it to the top in the new labels FDA has mandated.”
“In a little box at the top it will tell you everything a doctor needs to know before prescribing a drug,” Lesko said. “One would expect, when we have the case, to see genomic data at the top of a label for a new drug. So I think we are staged to really take advantage of this information when it’s appropriate.”
It wasn’t immediately clear if FDA will release a draft or final guidance. The agency didn’t say the exact date it plans to release the document.
New Law Aims to Reduce Financial Risk of Developing Biothreat Tools for US Gov't
A little-known bill enacted into law at the end of last year could be a boon to biotech companies, including those using genomic technologies, developing diagnostics for pathogens and other biosecurity-related products and services.
The Pandemic and All-Hazards Preparedness Act creates a new way for the federal government to contract out its biosecurity programs for biothreat responses, among other provisions.
It aims to reduce some of the risks faced by companies developing bio-threat technologies for the federal government.
Specifically, it will try to cover R&D costs for companies developing biothreat tools as NIH funding runs out but before Project BioShield kicks in, which can take between three and five years.
“The government is finally getting it,” David Persing, a vice president at Cepheid, told GenomeWeb News. “They’re finally understanding what companies need and how companies work.”
The Pandemic Act creates a new scaffold of powers, called the Biomedical Advanced Research and Development Authority, through which federal agencies are given more freedom to offer companies enticements to develop biothreat responses.
BARDA, which is slated to receive a $1.07 billion funding budget for fiscal years 2006-2008, will be used to supplement Project BioShield, which includes the Departments of Homeland Security, Agriculture, Energy, Health and Human Services, and the National Science Foundation, among other organizations.
Experts say BARDA may help re-fuel BioShield projects that appear to be stalled. Had the Pandemic and All-Hazards Preparedness Act been around in 2006 it might have helped vaccine developer VaxGen, which was promised $877.5 million by Health and Human Services to develop a vaccine for anthrax.
Working under Project BioShield, HHS eventually pulled the plug on the deal after VaxGen spent a reported $175 million out of its own pocket, with almost no federal matching funds. The deal had specified that VaxGen would not to be paid until it had a working product on the table ready to begin production.
In BARDA’s language, VaxGen could not get the project across the “Valley of Death” — the chasm between NIH-funded basic research and end-stage BioShield-backed development — and HHS would not offer a hand.
HHS spokesman Bill Hall said there are inherent and novel risks to developing biothreat products, and BARDA “will help some of these companies … get through that valley.”
Hall said all drug- and disease-related research is risky, but biothreat programs are doubly so. “There is a tremendous amount of money spent on biotech on cancer,” Hall explained, “but there have been many dead ends. The same is true for biotech or biosecurity. But [in biosecurity] you’re dealing with issues [such as terrorist attacks] which may not come to fruition.
“And there is not a built-in delivery system in place,” Hall continued. “For a cancer drug, there is a delivery system: hospitals, doctors, etcetera. …”
BARDA may help companies cross the Valley of Death by “authoriz[ing] us to spend more money for these programs,” Hall told GenomeWeb News. “This is not a new agency with a new staff. It is a new authority.”
BARDA “allows us more flexibility to offer advance payments” for biothreat contracts. “Or, if a company gets to point x in development, and they say they need an infusion of money, then the department can make a payment to that company,” he said.
Hall also said that BARDA has enabled HHS to develop an “infrastructure that will allow us to incorporate these new authorities” that will allow “HHS to take a leadership role to strategically define our biodefense countermeasure development.”
For HHS, Hall said, that will mean increased cooperation with the research industry.
“Once a threat has been assessed and decided on” by HHS or the Department of Defense, “part of it involves canvassing industry to find out what’s out there already, and going to them and saying, ‘We’re interested in developing a countermeasure,’” Hall said.
Then, HHS will be able to tell industry: “’We’re going to give you $500 million, and you need to meet certain milestones.”
Hill stressed that because the project is new, it is not yet clear where its funding will come from, how it will be overseen, or how it will be implemented.
Some in industry welcome the new bureaucracy. “What it says to me is that the government is finally getting it,” said David Persing, a vice president at Cepheid, which makes diagnostic tests for influenza, including a portable test designed to identify flu viruses within 24 hours. “They’re finally understanding what companies need and how companies work.”
As a contractor making a diagnostic for avian flu, for example, Persing said Cepheid might be likely to shy away from a restrictive contract.
“If [the government] had come up with a proposal and restricted it to avian flu, we’d say, ‘Well, why do we want to do that? We don’t even know if we’re ever even going to need” the tests. “Nobody is excited about that kind of business model. Everybody gets discouraged and interest starts to wane.”
BARDA looks promising to Persing because it looks to retool that model. “What they did was say, ‘How can we design this to allow companies to build a product they can sell year after year while developing a product that will allow us to be ready in case of a pandemic outbreak,’” Persing told GenomeWeb News. “That’s the kind of model that companies respond to.”
ABI/MDS Sciex, Pfizer, and Sound Analytics to Develop New ADME Software
Applied Biosystems, MDS Sciex, Pfizer, and Sound Analytics plan to develop software that will work with high-throughput automation technology to improve compound analysis.
The technology will focus on improving techniques for analyzing absorption, distribution, metabolism, and excretion.
By improving the “timeliness and accuracy” of information drawn from ADME testing, ABI said, the new software would increase the efficiency of the pre-clinical drug-development process.
Pfizer R&D Director Cornelis Hop said that because a swift analysis of the characteristics of compounds is a “major challenge in drug discovery,” drug makers “need a new approach that delivers rapid turnaround of ADME-related assay data.”
ABI proteomics researcher Laura Lauman said that the end goal of the project is to help drug makers kill bad compounds early and often.
The alliance is particularly meaningful for Pfizer. The company last year suspended a large, Phase III trial for the much-anticipated cardiovascular therapy torceptrapib/atorvastatin (T/A) due to an increased rate of mortality in patients receiving the combination compared to those receiving atorvastatin (Lipitor) alone.
Lipomics to Develop Dxs for Metabolic Diseases in Alliance With UCD
Lipomics and the University of California, Davis will study metabolic diseases with “an emphasis on personalized medicine,” the company said this week.
Lipomics uses bioinformatics and other analytical tools to develop profiles of lipid metabolites it can use to develop diagnostics for metabolic diseases.
Under the agreement, Lipomics will retain “certain rights to develop diagnostic applications based on the data from the studies,” the company said.
Financial terms of the agreement were not released.
Gene Logic Could Spin Off Genomics Unit as Review Continues; Q4 Revenues Slide 60 Percent
Gene Logic’s ongoing strategic review of its genomics division has led it to consider “a spin-off entity with a retained equity position or other alternative structures to capture value” for the company.
The company made the remarks last week while announcing its earnings for the forth-quarter ended Dec. 31, 2006, during which period Gene Logic’s revenues decreased 60 percent, R&D spending remained flat and net loss increased 133 percent.
Gene Logic began the review in June 2006. Five months later, during its third-quarter 2006 earnings call, the firm offered sparse details regarding the direction the genomics division will take, except to say that the company has “been evaluating strategic options … in areas such as clinical biomarker development and molecular diagnostics.”
Last week’s disclosure sheds some additional light on the options the company may have.
Total receipts for the fourth quarter fell to $7.1 million from $17.7 year over year. All of the company’s revenue came from its genomics services business.
Gene Logic reiterated in its earnings statement that it is “transforming” into a biopharmaceutical company, highlighted by the divestiture of its pre-clinical services division to Bridge Pharmaceuticals for $15 million during the quarter.
As Pharmacogenomics Reporter sister publication GenomeWeb News previously quoted Gene Logic CEO Mark Gessler saying the company is “driven in part by the continuing growth of our drug repositioning business.” Gessler cited recent deals with Eli Lilly, Pfizer, Roche, and Organon as examples of that growth.
Through that sale, the company reduced its workforce from 434 to 151 employees.
R&D spending was up slightly to $2.27 million from $2.15 million year over year.
The company said net losses increased to $5 million from $2.1 million in the year-ago period.
As of Dec. 31, Gene Logic had $50.1 million in combined cash, cash equivalents, and marketable securities available-for-sale
Researchers Have Sequenced 2,000 Flu Genomes; Data in GenBank
Researchers have sequenced the genomes of more than 2,000 influenza viruses and have deposited the data in GenBank, according to the National Institutes of Health.
The Institute for Genomic Research led the Influenza Genome Sequencing Project, which took place at the Microbial Sequencing Centers. The MSCs are part of the National Institutes of Allergy and Infectious Disease.
Other project collaborators include the National Center for Biotechnology Information, the Centers for Disease Control and Prevention, and several academic and clinical research institutions.
NIAID’s Maria Giovanni said that the influenza genome project has “vastly increase[ed] the amount of influenza sequence data,” and has led to more researchers putting more sequence data back into the public domain.
Additional information can be found here.