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Federal Legislation May Hobble PGx Innovation, FDA’s Lesko Cautions

ATLANTA — Federal legislation regulating pharmacogenomics and personalized medicine, including a bill submitted by Illinois Senator and Democratic presidential candidate Barack Obama, may be premature and could stifle potential breakthroughs in a nascent scientific field, a high-ranking FDA official said at the Drug Information Association’s annual meeting, held here this week.
“I have a lot of concern about legislation providing oversight of personalized medicine, for the same reason I have concerns about FDA writing guidance before it’s time,” said Lawrence Lesko, director of FDA’s Office of Clinical Pharmacology & Biopharmaceutics. “If you write guidance on a field that’s evolving … [it] can stifle the field.”
Lesko clarified that he was speaking as someone who is experienced in the healthcare regulatory arena and that his concerns do not reflect the FDA’s view.
“I have concern that this field is so rapidly evolving that the attempt to regulate it or even regulate the genetic testing area is going to stifle innovation,” he said. “I think there [are] other ways to get to the same end product, and it’s not federal regulations.”
Lesko highlighted the co-development of Pfizer’s HIV tropism drug maraviroc and Monogram’s Trofile assay [see PGx Reporter 12-06-2006], noting that premature federal regulation could hinder such “breakthroughs.”
“I think we need to be careful about over-regulating the field and not allowing it to grow and mature as we move forward,” he said.
Lesko noted that guidelines from professional organizations and guidances from regulatory agencies may provide a more appropriate framework for regulating the field. He said at the DIA meeting that the FDA had submitted its comments to the bill, but Obama’s staff claims to not have seen them.
“They say it’s a good thing when Congress takes notice of something … [but] I have a lot of concern about legislation and its oversight,” said Lesko, adding that he would be similarly concerned if FDA prematurely issued guidances.
Coincidentally, diagnostic developers have criticized the FDA’s recent efforts to regulate certain lab-developed tests for the very same reasons Lesko expressed concern about Obama’s bill. Laboratory test developers have cautioned that FDA oversight of a subset of algorithm-based tests called in vitro diagnostic multivariate index assays would stifle innovation [see PGx Reporter 02-14-2007].
An FDA spokesperson stressed, however, that Congressional “regulations are different from [FDA-issued] guidances.” While regulations are legally binding and require more time, effort, and clearances to modify or update, guidances are recommendations and are not binding. “They are updated easily as science advances,” the FDA spokesperson said.
Some in the industry welcome federal legislation. Johns Hopkins University’s Genetics & Public Policy Center, for one, is actively engaged in genetic policy discussions on the Hill and feels that Congressional involvement in regulating genetic tests is timely now because the field is so rapidly advancing.
“We are pleased that Congress is paying attention to these very important issues that have a significant impact on the health of the public,” GPPC Director of Law and Policy Gail Javitt told Pharmacogenomics Reporter in an e-mail this week.
According to Javitt, GPPC does not have a position on whether Obama’s bill would stifle innovation. However, she said that the center believes “the success of personalized medicine is predicated on the availability of safe and effective genetic tests and public confidence in them, and that the current inadequacies in the regulatory environment for genetic tests may hinder the success of personalized medicine.”   
Premature Legislation?
Obama originally introduced his “Genomics and Personalized Medicine Act” in August 2006 to the Senate Finance Committee. He reintroduced a heavily revised version in March to the Senate’s Health, Education, Labor and Pensions Committee that removed a section granting incentives to certain diagnostic developers.
Another section that would contract the Institute of Medicine to study the regulation of genetic tests has been broken out as an amendment to the Food and Drug Administration Revitalization Act (S.1082) (see related story, this issue).
Obama’s bill has been both commended for its timeliness and criticized as too broad. Stakeholders in Washington closely tracking the bill have said that congressional involvement can improve public health by ensuring the safety of genetic tests and increasing awareness of the science.
Some have suggested, however, that in order to improve the legislation’s chances for passage, Obama will need to focus the bill closer to a bill submitted by HELP committee chair Edward Kennedy (D-Mass.). [see PGx Reporter 11-21-2006]. Kennedy’s legislation is called the “Laboratory Test Improvement Act.”
According to Dora Hughes, legislative assistant to Obama on health and education issues, the major point of contention in comments to the bill surround the oversight of genetic tests.
“In comments we’ve received, some say that the Kennedy bill’s regulation of laboratory-developed tests is too strong, and others say that the Obama legislation is not strong enough,” Hughes said at the DIA meeting. “Somewhere in the middle is the answer.”
Hughes, who was formerly Kennedy’s legislative advisor, said Obama’s bill will be further changed in the coming weeks. “None of us on the Hill are genomic experts, so there will be additional changes to the legislation, no doubt,” she said, adding that the senator’s staff is hoping to get the bill passed through the HELP committee and through the Senate by the end of the year.
She added that the “regulatory aspects” of the bill will be the subject of “heavy discussion in the markup of the bill.”
“We are awaiting formal comment by the administration, which we expect early this week, telling us how better to strengthen our legislation in terms of larger issues and technical feedback,” Hughes said.

“I think we need to be careful about over-regulating the field and not allowing it to grow and mature as we move forward.”

Obama’s staff is also formulating recommendations for genetic testing regulations and working with members in the House of Representatives to introduce similar legislation regarding personalized medicine.
Less Funding, No Tax Incentives
The most current iteration of the Genomics and Personalized Medicine Act has reduced the amount of funding requested for the various PGx-related proposals.
For instance, it has sliced $4 million from an original $5 million proposal to form an Interagency Working Group that would coordinate genomic initiatives, standardize genomic terminology, establish quality standards, and promulgate guidelines for the handling of genomic data, genetic samples, and patient information.
In addition, the new version of the bill cuts in half a $250 million proposal to develop a biobank of genomic data, and HHS-directed efforts to improve genetic training for healthcare professionals, which would have received $10 million under the previous version of the bill, also saw a 50-percent decrease.
The appropriations requested in the bill are for one fiscal year; the legislation includes provisions for reauthorization of the funds for five years.
Missing entirely from this version of the bill is a section outlining tax incentives for diagnostic developers. The original version of Obama’s bill included an “incentive-specific section, which had to be stripped from this current iteration in order for the bill to be within the jurisdiction of the HELP committee,” Hughes explained.
The only provision remaining in the current version in this regard is the proposal for a National Academy of Sciences study recommending incentives that would encourage drug/diagnostic co-development and the development of companion diagnostics for marketed drugs. Set aside for this study, the implementation of a “decision matrix” (see sidebar) to improve oversight of genetic tests, and an Institute of Medicine study reviewing the oversight of genetic tests, is $6 million, down from $10 million in the previous iteration.
Edward Abrahams, executive director of the Personalized Medicine Coalition, told Pharmacogenomics Reporter this week that Obama’s staff has asked the coalition to look into incentives options for diagnostics developers. The PMC has formed a working group studying the matter. The group will report its findings to Obama’s staff for inclusion in the current personalized medicine bill or in other legislation.
Abrahams disagreed that Obama’s bill would stifle PGx innovation. Instead, he said, the bill “heightens the discussion regarding personalized medicine.
“It is really exciting that someone who is running for President of the United States has taken an interest in this issue,” Abrahams said. “Besides, I’ve never encountered a government agency that thought that Congress was doing a good job.”

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