Energy & Commerce Chair Muscles in on Steroids
In a statement April 26, House Energy & Commerce
Committee Chair Joe Barton (R-TX) applauded the introduction of
the “Drug-Free
Sports Act,” H.R.1862, signaling the Committee will act
on the legislation this year.
H.R.1862 was introduced by Rep. Cliff Stearns (R-FL)
and cosponsored by Reps. Charlie Bass (R-NH), Marsha Blackburn (R-TN),
Fred Upton (R-MI),
and Gene Green (D-TX), all members of the Committee to which the bill
is referred. It is also referred to the committee on Education &
the Workforce; Blackburn and Upton are also members of this committee.
Barton stated steroid use has “tarnished baseball for
a generation of fans,” and the legislation is needed to spur
action in professional sports to address problems there and also to “put
us on the right path” to stop steroid use among young people
hoping to be better athletes or models.
The bill would require the Secretary of Commerce to establish and
enforce drug-testing policies for professional sports, including requiring
annual random testing and testing for all substances listed by the
World Anti-Doping Agency and other substances identified by the Secretary
and establishing mandatory penalties to include lifetime suspension
for a second offense. Sports associations that did not comply with
the requirements could be fined $5 million for the initial offense
and $1 million per day for each subsequent day of non-compliance. The
bill also would require the Government Accountability Office (GAO)
to study and report on drug testing policies of high schools and colleges,
and recommend whether similar legislation is needed for them.
The Energy & Commerce subcommittee on Commerce, Trade,
and Consumer Protection, chaired by Stearns, will hold a hearing on
the legislation
on May 5.
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Grassley, Dodd Introduce Drug Safety Bill
Sens. Chuck Grassley (R-IA) and Chris Dodd (D-CT)
made good on their promise April 27 to introduce legislation to improve
FDA’s
focus and activities related to drug safety. S.930 would amend the
Food, Drug & Cosmetic Act to establish a new Center for Postmarket
Drug Evaluation & Research (CPDER) in the office of the FDA Commissioner.
The Center would be responsible for all postmarket activities related
to approved drugs and be authorized to require product sponsors to
conduct postmarket studies and to “take corrective action” if
the Center Director determines the product may pose an “unreasonable
risk [when considering risk compared to benefit] to the health of patients
or the general public.”
The bill would require the director of CPDER to review
all applications and analyses associated with applications at the pre-market
phase,
continuing this review regardless of whether an application is approved
in the interim, but would not permit the review to delay the approval.
As a result of this review, as well as at any time after the product
is on the market, the director would be authorized to require post-market
studies. Sponsors would be required to submit post-market study progress
reports at least every 90 days; FDA would be required to publish, at
least every 90 days, a list of required and pending post-market studies
and their status and results. Civil monetary penalties would be established
for failure to conduct the required post-market studies and the product
could be misbranded. Based on the results of such studies, or on other
information, the Center director would be authorized to “order
a corrective action.” Consultation with the Director of the Center
for Drug Evaluation & Research (CDER) and/or the Director of the
Center for Biologics Evaluation & Research (CBER) would be required.
“Corrective actions” could include label changes (sponsors
would be required to change the label as directed, by a specified date),
restricted distribution, patient registries, additional (or new) patient
informed consent, monitoring sales and use of the product, and risk
management plans. In addition, limitations would be placed on promotion
of the product. Civil money penalties also would be authorized for
failure to take a required corrective action, and the product could
be misbranded.
If a product is determined to pose “unreasonable
risk,” promotional
materials would need to be pre-cleared by FDA and could be required
to present information about the risk and about corrective actions
under way, outstanding post-market studies, and information about other
products (if any) that could treat the condition and have a more favorable
benefit-to-risk profile. Similar requirements also would be authorized
for new products during the first two years on the market.
The CPDER director would be authorized to take the
ultimate “corrective
action,” removal of a product from the market, under expedited
procedures to be outlined in regulations promulgated within one year
of enactment. Consultation with the director of CDER and/or CBER, and
public notification of the action and the reasons for it, would be
required.
The bill would require biannual meetings of the Drug Safety and Risk
Management Advisory Committee, to discuss ongoing and completed studies,
specific risk assessments, and general drug safety issues, and make
recommendations to FDA. Among the recommendations would be whether
and which products pose an “unreasonable risk.”
Finally, the bill would require FDA to submit a report to Congress
on processes for post-market surveillance of devices, including recommendations
for change and identification of necessary legislation.
All drug safety functions would be transferred from CDER and CBER
to CPDER under this bill. Funds would be authorized to carry out the
provisions of the bill: $50, 75, 100, 125, and 150 million for FY 2005-2010.
While several public interest groups praised the legislation,
Senate Health, Education, Labor, & Pensions (HELP) Committee Chair
Mike Enzi (R-WY) expressed concern, stating drug safety functions
should
not be separated from review functions at FDA. This, he said, would
result in confusion for doctors and patients, as a result of measuring
the risks and benefits of products “on two separate scales.”
Since S.930 is referred to the HELP Committee, support
of the committee chair presumably would be an important criterion for
getting action.
So, the prognosis appears doubtful for this specific bill, although
not necessarily for drug safety legislation per se.
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“Bioshield II” Introduced
On April 28, Sens. Orrin Hatch (R-UT), Joe Lieberman (D-CT), and Sam Brownback
(R-KS) introduced S.975 (Bioshield II), to “provide incentives to increase
research by private sector entities to develop medical countermeasures to
prevent, detect, identify, contain, and treat illnesses, including those
associated with biological, chemical, nuclear, or radiological weapons attack
or an infectious disease outbreak.”
This bill is essentially the same as one introduced in the last Congress
by Hatch and Lieberman, and would provide for tax incentives, intellectual
property protections, and liability protections for companies to help attract
and maintain private sector investment in the development of countermeasures,
as well as new antibiotics and vaccines for biological threats such as infectious
diseases, genetically manipulated materials, and antibiotic-resistant organisms.
In his discussion of the bill, Lieberman noted the intention to shift from
a “defense contractor model” of private companies working with
the government, to a model under which the federal government is a “reliable
partner.” This, he said, is the only way to attract successful companies
that have brought products to market. The rewards under the legislation would
be achieved only if a company participating in a project with the government
is successful in developing the necessary product.
Incentives/rewards for success include the following:
A choice of tax incentives – (1) allowing establishment
of an R&D
Limited Partnership, where all partners receive the tax advantages;
(2) allowing a special class of stock to be issued for which investors would
receive a
zero capital gains tax rate for any capital gains; or (3) a special
tax credit pertinent to the research
A choice of patent incentives – (1) the product’s
patent life would equal the patent term at the time of issue (no loss
of time from FDA
review, for example) or (2) the company would be allowed a two-year
extension on the patent of any of its products (“wild card” extension),
if the company has $750 million or less in paid-in capital.
In addition, the bill would establish a 10-year market exclusivity for the
countermeasure and provide for liability protections for the company that
develops a countermeasure.
There have been discussions in the Senate about beginning
consideration of a “Bioshield II,” but it is not clear which
provisions of already introduced legislation (S.3 as well as S.975
to date) or new bills
would be included in a “final” package. Sen. Richard Burr (R-NC),
new chair of the Health, Education, Labor, & Pensions subcommittee on
Bioterrorism and Public Health Preparedness, has indicated he wants
to hold hearings and begin consideration of legislation at some point
this year.
No discussions are reported in the House.
Return to top House Subcommittee Acts on Four
Health Bills
On April 27, the House Energy & Commerce subcommittee
on Health considered and reported to the full committee H.R.869,
184,
and 1812 and H.Res.169.
H.R.869 would amend the Controlled Substances Act (CSA) to remove the 30-patient
limitation on prescribing opiates to treat opiate dependence, for physicians
in group practices.
H.R.184, the Controlled Substances Export Reform Act, would amend the CSA
to allow for the export of certain controlled substances with subsequent
further export from the receiving country.
H.R.1812, the Patient Navigator Outreach & Chronic Disease
Prevention Act, would authorize grants under the Public Health Service Act
for the development
and operation of patient navigator programs and the training of individuals
to serve in that capacity. A patient navigator is defined as an individual
who assists patients in navigating the health care system, including
helping with coordination of care, informing patients of availability of
clinical
trials, helping patients communicate effectively with health care providers,
reaching out to community organizations to provide additional services
to patients, etc. This would be a demonstration program requiring a report
to
Congress.
H.Res.169 is a resolution to recognize the importance of sun safety to prevent
skin cancer.
The bills passed through the subcommittee uneventfully, with an expectation
they will be taken up by the full committee shortly.
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New Guidelines for Human Embryonic Stem
Cell Research
This week the National Academies of Science released
a report on guidelines for embryonic stem cell research, with the main
recommendation being
all institutions studying stem cells should establish oversight committees
that include members of the public, as well as experts in scientific,
legal, and ethical issues. The 131-page report contains more than 50
specific recommendations covering everything from good recordkeeping
to ensuring future stem-cell medicines are accessible to all racial
groups.
Additional guidelines cover areas such as researchers
not paying donors for eggs or other human tissues, and not injecting
human
stem cells
into monkey embryos. The guidelines, while not binding, are expected to help states and
private research institutes move forward with research plans despite
the continuing debate in Washington over federal funding for stem-cell
research.
A Wall Street Journal article cited how adopting
these recommendations could prove onerous to small biotechnology companies.
Robert Lanza,
medical director of Advanced Cell Technology Inc., based in Worcester,
MA., said despite some concerns over the report's wording, he
agreed there was a need for national guidelines. "Right now you
can do anything, and the potential abuse in this area is very considerable," he
said.
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House Ag Subcommittee
Hears Recommendations on Soybean Rust
With the USDA announcement of the first soybean rust
detection in 2005 in Georgia, trade groups told a joint House Agriculture
Committee subcommittees
hearing this week that while much has been done to prepare for a wide
scale outbreak of the plant disease, more government action is needed.
The subcommittees on Conservation, Credit, Rural Development
and Research, and General Farm Commodities and Risk Management met
jointly April
27 to hear testimony on what actions are needed to contain a U.S. outbreak
of soybean rust, a fungal disease that stunts or kills
soybean and other plants. Soybean rust has devastated soy crops in
Latin America
in recent years.
The American Soybean Assn. (ASA) told the hearing
its main concern is there may not be enough fungicide to deal adequately
with an outbreak, a situation complicated by distribution problems
and a
lack of application equipment and custom applicators. Both industry
and government are working to ensure a variety of fungicides are registered
to treat soybean rust.
ASA wants USDA to coordinate with manufacturers and
distributors first to determine available supplies and then to make
sure farmers have
access to the chemicals nationwide. ASA is also asking Congress to
appropriate $2.1 million for soybean rust research in FY2006.
Return to top Conner Approved as Deputy USDA Secretary
Chuck Conner’s nomination to be deputy secretary
of USDA was approved by the full Senate this week after Sen. Larry
Craig (R-ID)
lifted his hold on the nomination. Conner, previously Special Assistant
to the President for Food, Agriculture and Trade, had sailed through
his Senate Agriculture Committee confirmation hearing, only to be sidetracked
when Craig, frustrated by the Administration’s ongoing finagling
with the payment rules on U.S. agricultural sales to Cuba, tried to
get the White House’s attention by putting a hold on the Conner
nomination.
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Portman Clears Senate to be New Special Trade Rep
Rep. Rob Portman (R-OH) was confirmed by the Senate this week to be
the new U.S. Trade Representative, fulfilling Senate Finance Committee
Chair Chuck Grassley’s (R-IA) promise to have Portman in his
new role in time for a mini-ministerial GATT meeting May 2 in Europe.
Last week during his confirmation hearing, Portman promised to negotiate
controversial sugar provisions in the stalled CAFTA treaty.
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Johnson Confirmed As EPA Administrator
Acting EPA Administrator Stephen Johnson's nomination to become permanent
head of the agency was finally approved by the Senate this week. The
nomination had been blocked from a Senate vote by Sen. Thomas Carper
(D-DE) because of his frustration with EPA and the White House’s
alleged foot-dragging over a request for technical analyses of the
environmental, health and economic benefits of competing air quality
proposals, including Bush's and Carper's plans. Carper said he supported
Johnson’s nomination, and that his frustration was with the White
House “and its continued refusal to provide me with information
on my clean air bill and other proposals before Congress.”
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Dorr Confirmation Hearing Brings Out Harkin Opposition -- Again
Iowa farmer and businessman Tom Dorr has been nominated
twice to be USDA undersecretary for rural affairs and both times Sen.
Tom Harkin
(D-IA) has come out against the nomination in a major way. This week,
during Dorr’s second confirmation hearing, both men stuck to
their guns, with Harkin leveling the same list of allegations about
misuse of USDA farm programs and racial attitudes, and Dorr denying
them.
Dorr dismissed Harkin’s allegations and refused
a Harkin offer during questioning to state his regret publicly for
past public statements.
Dorr said he never misrepresented his farming operations to USDA, though
USDA did disallow a Dorr family farm filing that ultimately required
the repayment of some farm program payments.
Dorr served as acting undersecretary during the first Bush term after
the President gave him a recess appointment. When that expired, Dorr
served as a special advisor to Secretary of Agriculture Ann Veneman,
a position he still holds with Secretary Mike Johanns.
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Cuba Trade Battle Focus of New Coalition
About 30 U.S. companies and trade associations from 19 states have
banded together to create a new coalition to battle for liberalization
of trade with Cuba, protecting current trade rules and eventually establishing
full trade between the two countries.
Charter members of the U.S.-Cuba Trade Association include Cargill,
Inc., ADM, Caterpillar, USARice Federation, North Dakota Farm Bureau,
Louisiana Department of Economic Development, Port Manatee Commerce
Center and the Virginia Department of Agriculture.
The group strongly supports legislation introduced in Congress to
expand trade with Cuba, and also has thrown its backing behind legislation
introduced this week to relax travel restrictions to the island nation.
On a conference call this week between the group and
Pedro Alvarez Borrego, chair of the Cuban food import agency Alimport,
the Cuban
official said U.S. farmers and companies have lost out on $300 million
in food sales since February when the Bush Administration imposed new
strict payment rules on U.S.-Cuban food/agriculture transactions. Borrego
said “uncertainty of supply and financial losses” forced
his agency to “detour” purchases to other foreign markets.
Alimport has imported $179.4 million in U.S. food products this year,
about the same as in recent years; however, the new Cuban trade group
said business is not growing this year.
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Craig Introduces Railroad Competition Act Of 2005
Sen. Larry Craig (R-ID), along with Sen. Conrad Burns
(R-MT), introduced this week the Railroad Competition Act of 2005,
a bill they said will
foster rail competition in areas of the country underserved by major
railroads, by streamlining the process of resolving rate and service
disputes.
The bill would require rail customers to receive rate
quotes for movements between various points on a rail system; free
regional and short line
rails to access major systems; provide captive rail customers who
can’t afford to buy into rate challenge proceedings access to
arbitration and direct the Surface Transportation Board (STB) to adopt
a more “realistic and workable rate reasonableness standard.”
Craig said areas of the country served by only one or two carriers
suffer from lack of competition, resulting in producers passing higher
costs of production back to consumers. “This bill seeks to return
the power to the customers and bring capitalism back into many regions
where rail shipping has strayed into monopoly,” Craig said.
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BSE UPDATE
U.S. Team Sees Japan Moving Toward Reopening Markets,
But Slowly
Press reports out of Japan this week indicate the U.S. technical
team meeting with officials in Japan and Korea see progress toward
reopening beef trade, but they continue to be frustrated with the
pace at which the process is moving. Chuck Lambert, the USDA deputy
under secretary who led the team, told Associated Press that all
technical conditions for resumption of Japanese beef imports have
been met.
“We’re seeing signs of progress in the right direction,” he
said. “We believe the progress is painfully slow.”
Return to top
Kansas Study Says Private Cow Testing Could Be Valuable
A Kansas Department of Agriculture economic study released this
week says voluntary BSE testing could provide economic gain to the
beef industry despite additional test costs. The study also showed
the U.S. beef industry has lost $3.2-4.7 billion over the last year.
Slow progress in reopening the Japanese market will also mean these
numbers will expand significantly, said state Secretary of Agriculture
Adrian Polansky. The report, which looked at regulator costs, losses
and consumer reactions after the 2003 discovery of a BSE cow in Washington
State, showed profits from beef exports would more than pay for voluntary
testing, estimated to cost about $640 million for all cattle slaughtered
in the U.S.
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New Bills
A number of new bills have been introduced. Click
here to send a request for a copy of the text or more information about
the bill.
S.CON.RES.30
Sen. Richard Durbin (D-IL) offered a concurrent resolution to express
the sense of Congress concerning the provision of health insurance
coverage to all Americans.
S.908
Sen. Mitch McConnell (R-KY) introduced the “Commonsense Consumption
Act of 2005'' to allow “Congress, State legislatures, and regulatory
agencies to determine appropriate laws, rules, and regulations to address
the problems of weight gain, obesity, and health conditions associated
with weight gain or obesity.”
S.930
A bill offered by Sens. Chuck Grassley (R-IA) and Chris Dodd (D-CT)
would amend the Food, Drug, and Cosmetic Act to establish a new Center
for Postmarket Drug Evaluation and Research (CPDER) in the office
of the FDA Commissioner.
S.934
Sens. Russell Feingold (D-WI) and Lindsey Graham (R-SC) offered legislation
to “establish an expedited procedure for congressional consideration
of health care reform legislation.”
S.969
Sen. Barack Obama (D-IL) introduced a bill on “preparation for
an influenza pandemic, including an avian influenza pandemic.”
S.975
Sens. Orrin Hatch (R-UT), Joe Lieberman (D-CT), and Sam Brownback (R-KS)
introduced “Bioshield II” to “provide incentives
to increase research by private sector entities to develop medical
countermeasures to prevent, detect, identify, contain, and treat
illnesses, including those associated with biological, chemical,
nuclear, or radiological weapons attack or an infectious disease
outbreak.”
Return to top
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