Eli Lilly, which has increasingly been striving to employ pharmacogenomics in its drug-discovery efforts, recently awarded Johns Hopkins University’s Genetics and Public Policy Center a $110,000 grant to study regulatory impediments that slow the commercialization of pharmacogenetic drugs and diagnostics in the US.
The GPPC last month said it will use the grant to “research the current regulatory process for pharmacogenetic drugs and devices, identify impediments to pharmacogenetic innovation and adoption by health care providers, and propose regulatory reforms.”
The study, which began in October and is expected to end by September 2009, could also shed light on products in Lilly’s pipeline, particularly since the drug giant is actively using PGx strategies to guide drug development.
Gail Javitt, GPPC’s law and policy director, told Pharmacogenomics Reporter this week that the decision to conduct the study was “based on issues of mutual interest to both Lilly and GPPC.”
“Pharmacogenetics promises improved pharmaceutical safety and effectiveness by tailoring drugs to patient genetic information. This goal has been largely unrealized,” the GPPC said in a statement announcing the Lilly agreement. “The regulatory pathway for drug and device approval and for updating drug labels is not well-suited to respond to the new pharmacogenetic paradigm.”
One area of examination for the GPPC/Lilly study will be the regulatory process for getting PGx data into drug labels. To this end, GPPC plans to investigate whether the regulatory process “is optimal to provide timely and useful information to providers in making prescribing and dosing decisions,” Javitt said.
The FDA has said it plans to highlight pharmacogenomic information more prominently in drug labels.
In a 2006 study, the FDA identified as many as 121 marketed drugs that contained PGx data in their labels. The agency at the time said it had begun the process of creating a database of such information. The genomic information in this database is linked to PubMed to allow researchers to reference the latest findings on gene-drug response associations of interest.
“The regulatory pathway for drug and device approval and for updating drug labels is not well-suited to respond to the new pharmacogenetic paradigm.”
As part of its study, the GPPC said it plans to sift through case studies of pharmaceuticals for cancer, sepsis, and neurological disorders, and interview FDA and industry officials.
Also factoring into GPPC’s analysis will be recently released reports on pharmacogenomics, genetic tests, and personalized medicine by the HHS Secretary’s Advisory Committee on Genetics, Health, and Society; and the President’s Council of Advisors on Science and Technology.
“At this point I can’t say with specificity in what ways our study will differ [from those previous reports], but I suspect our focus will be both narrower and deeper in trying to developing options to optimize the regulatory process for PGx,” Javitt said.
According to the GPPC, the intended audience for the report is policymakers, most notably members of HHS and Congress, entities that oversee the FDA.
GPPC’s announcement of the grant came around the same time that Lilly disclosed it had hired pharmacogenetics consultancy Cabernet Pharmaceuticals to help it reduce attrition in clinical trials, improve its luck with US Food and Drug Administration submissions, and develop new blockbuster drugs [see PGx Reporter 11-12-2008].
GPPC, created by the Pew Charitable Trusts in 2002 to help policymakers and the public understand the issues and barriers associated with genomic medicine, has urged the FDA for clearer guidance and consistent regulation of genetic tests. The group has particularly criticized the FDA’s decision to regulate in vitro diagnostic multivariate index assays, a subset of complex laboratory developed tests, as “piecemeal” and not “risk-based.”
GPPC officials have in the past asserted that the agency’s approach toward genetic tests creates “an unstable business climate that may deter the development of new, clinically valid genetic tests,” and discourages investors from backing such products.
In deciding to regulate IVDMIAs, the FDA released two draft guidances describing its plan in 2006 and in 2007, and hosted a contentious public meeting in February 2007 to defend its strategy. Although the final guidance was expected to be released this year, the FDA has not provided any update on the document’s status. [see PGx Reporter 02-14-07].
Lilly declined to comment for this article.