Sen. Barack Obama’s (D-Ill.) recently introduced pharmacogenomics bill may have a better chance of being passed in the new Democratically controlled Congress if it is reintroduced to align with the agenda of the incoming chairman of the Health, Education, Labor and Pensions committee, Edward Kennedy.
Also, because Obama is considering running for President in 2008, some in the life sciences industry believe his bill will draw positive attention toward smaller biotech companies and away from pharmaceutical behemoths that have been slow to embrace newer technologies.
Obama became a member of the HELP committee when the Democrats took control of Congress in mid-term elections earlier this month. This committee has jurisdiction over the regulatory components of his “Genomics and Personalized Medicine Act of 2006,” which was introduced in August [see 8/9/2006 PGx Reporter].
Simultaneously, Sen. Edward Kennedy (D-Mass.) has become the chairman of the HELP committee and plans to introduce a bill of his own, “The Laboratory Test Improvement Act,” which aims to ensure that diagnostic “tests developed in the laboratories are of proven validity.” (see related article, this issue)
Kennedy’s legislation aims to clarify the FDA’s authority to regulate tests that “some have questioned,” and guide the agency in how to exercise its power in this regard. Additionally, the bill will “clarify [that] when FDA has cleared or approved a diagnostic, similar lab tests must also be cleared or approved by FDA,” the release states.
The proposed Kennedy legislation appears to support a draft guidance the FDA issued in September that seeks to encourage molecular diagnostic companies to file for pre- and post-market review tests that use an algorithm to generate results from multiple data points, rather than following traditional homebrew rules [see 9/13/2006 PGx Reporter].
As Pharmacogenomics Reporter reported in August, Obama’s bill is the first significant piece of legislation addressing pharmacogenomics, and if approved into law it could have broad implications for the development of molecular diagnostics and targeted therapeutics.
This week, with a Democratically controlled Congress set to begin in January, it looks like the bill might need to be redrafted if it hopes to be passed.
“The dynamics for [Obama’s] bill have changed,” Genetics and Public Policy Center Director Kathy Hudson told Pharmacogenomics Reporter. “Barack Obama introduced his bill in this Congress and it’s likely that he will re-introduce it in the next Congress.”
According to Hudson, any reformulation of Obama’s legislation will likely involve aligning it closer to Kennedy’s efforts.
An Obama/Kennedy Alliance on PGx?
Obama’s bill covers a lot of ground, and that may be its biggest weakness.
Among other things, it seeks to create a new Genomics and Personalized Medicine Interagency Working Group under the auspices of the US Department of Health and Human Services.
Such a group would regulate the rate and scale of genomics research, physician education, and incentives for developing genomic diagnostics and drugs. It would also regulate genetic tests under the Clinical Laboratories Improvement Act, oversee genomic privacy and direct-to-consumer advertising, and create a tax credit for developers of certain companion diagnostic tests.
Although, as written, it would have broad implications for the development of molecular diagnostics and targeted therapeutics, the legislation’s expansive scope may ultimately end up hurting its chances of passage.
“The bill has research implications, it has reimbursement implications, it has oversight and regulatory implications. So, the problem when bills are so broad in their scope is that they end up in referrals to multiple committees,” Hudson said.
However, Kennedy’s bill, which is much narrower, and Obama’s bill could work together because both try “to ensure the quality of the diagnostics that are going to be the foundation for pharmacogenetics,” even if they “take different approaches,” according to Hudson.
“Given that they are now in the same committee and in the majority, I would think that there would be some effort now, to make those two approaches consistent,” she said.
Obama’s bill contains provisions for $10 million to regulate the quality of genetic tests, including creating a genetic testing specialty under CLIA; and $30 million to regulate advertising for DTC genetic tests. The bill also encourages legislation of genetic privacy and non-discrimination.
For genetic tests that do not require pre-market approval by FDA, Obama’s bill asks the Centers for Medicare & Medicaid Services to develop criteria for establishing analytic and clinical validity, specify requirements for proficiency testing for laboratories, provide guidance regarding the scope of duty for laboratory directors, and make such information easily accessible to the public.
Kennedy’s draft bill addresses similar issues but is more specific in asserting FDA’s authority to regulate genetic tests.
While “Obama’s bill has a number of studies and inter-agency working groups and basically tells HHS to please come up with a system for overseeing the quality of genetic tests, it doesn’t itself proscribe it,” Hudson said. By comparison, the Kennedy bill “lays out a very specific plan for its expectations of how genetic tests would be regulated.”
Obama’s office would not comment on strategic plans for the legislation. Spokesman Tommy Vietor stopped short of gauging the bill’s prospects in the new Congress, but said: “It’s a good sign now that the Democrats are in control of the Senate; it gives us a better opportunity to advance the legislation.
”It’s a bill that’s a priority for Senator Obama and we hope to work on it in this Congress,” Vietor added. “I just couldn’t tell you, with a straight face, whether a bill is going to pass or not.”
Kennedy spokeswoman Laura Capps said that the Kennedy bill will likely be introduced in the beginning of 2007. Although, there are no efforts underway to unite the two Senators’ legislative efforts, it is something “we wouldn’t be opposed to considering,” she said.
Obama’s PGx Platform Raises PGx Profile
“The bill has research implications, it has reimbursement implications, it has oversight and regulatory implications. So, the problem when bills are so broad in their scope, is that they end up in referrals to multiple committees.”
Ultimately, for the PGx bill to pass, a Democratic Congress may not be enough. A change at the very top may be necessary. “The new Democratic Congress is good for their initiatives … but the real inflection point is going to change if a Democrat goes into the White House,” said Sam Tetlow, a principal with Clearview Limited, a consulting service in Raleigh, NC.
Whether Obama’s bill passes or not, its mere introduction by a high-profile senator and a potential 2008 presidential candidate raises the profile for pharmacogenomics in policy circles.
Obama “announced his interest in running for president and this is one of the pieces of legislation that he is behind,” Tetlow said. “This is one of the core pieces of legislation that he is leading, so it’s telling that here is a possible presidential candidate using this as a platform to run on in part.
“It focuses the attention on this issue, among a lot of different issues that exist in the US,” Tetlow said.
In Tetlow’s view, the Obama legislation will draw positive attention toward smaller biotech companies and away from pharmaceutical behemoths that have been slow to embrace newer technologies.
“How this affects pharmacogenomics, in terms of the Democratic wins in the House and the Senate in the midterm elections, is very much a positive,” he said. “The trend, if you think about it from a party perspective, is much more toward big pharma and established companies with a Republican Congress in session. With a Democratic Congress in session there is much more momentum behind introducing more of a disruptive technology base to the established companies that exist in the marketplace.”
According to Tetlow, “pharmacogenomics is one of those provocative and interesting things that does disturb the order in the marketplace away from big companies and to smaller companies.”
While, large pharmaceutical firms “leading the charge on pharmacogenomics-based advancements” will be in an advantageous position, “some other large companies that are not … will get hurt.”