HELP
Committee Sets Importation Hearing Date
The Senate Committee
on Health, Education, Labor, and Pensions (HELP) has announced its
hearings – promised to Senator Dorgan (D-ND)
at the time of the Senate’s consideration of the nomination of
now-HHS Secretary Mike Leavitt – on prescription drug importation
legislation. The Committee will here testimony on the first day (February
16) from Surgeon General
Richard Carmona, on the subject of "The Realities of Safety and Security."
Dr. Carmona is expected
essentially
to
redux
the testimony
he presented to the Senate Aging Committee. The bottom line of that
testimony, based on the legislatively mandated Importation Task Force
report, was that while safe prescription drug commercial importation
may not be impossible, the resources required to accomplish it are
enormous. Further, the Task Force determined that realistic cost savings
to consumers are far less than what has been touted, as many of the
drugs being imported have generic versions available in the U.S. at
lower cost than the imported versions. The second day (February 17),
"Drug Importation: Would the Price be Right?" will focus on price and
cost
issues; including
the recently released Consumer Department study on foreign pharmaceutical
price controls.
Senator Dorgan re-introduced
his importation legislation, S. 334, on February 9, along with 34
cosponsors. In
remarks accompanying the
bill introduction, Senator Dorgan stated that the bill has been modified
from last year’s version, in response to input “from various
stakeholders.” Specifically, he said, he has addressed
the safety issues “thoroughly and proactively” and resolved
concerns about the bill’s potential for creating trade problems.
By resolving trade concerns, he said, he has secured the support
of Finance Committee Chair Chuck Grassley (R-IA). Finally, Senator
Dorgan pointed out that parallel trade has been a fact of like in the
European Union for many years, with no adverse safety consequences.
Dorgan predicts that the votes are there in the Senate to pass this
legislation.
Companion legislation was introduced in the House (H.R. 700) by Representative
JoAnn Emerson (R-MO), with seven cosponsors.
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House
Government Reform Committee Examines Flu Vaccine Issues
On February 10, the House committee on Government
Reform held a hearing entitled “Managing This Season’s Flu Shot Supply and Preparing
for the Future.” In his opening statement, Chairman Tom Davis
(R-VA) noted the Committee’s continuing involvement and interest
in immunization and vaccine issues and expressed the hope that witnesses
would explain why a shortage of flu vaccine now had turned into a surplus.
Dr. Julie Gerberding,
Director of the Centers for Disease Control and Prevention, described
actions CDC has taken
in the ’04-’05 flu season, as well as plans for the future.
She stated to avoid shortage situations in the future, it is critical
to stabilize and strengthen the vaccine market, develop financial incentives
for vaccine manufacturers, and consider optional creative approaches
to securing sufficient vaccine availability. Among options being considered
are possible use of vaccines under an IND, as a back-up in the event
of a shortage, as well as use of lower doses, if such dosage can be
shown to be effective. Finally, Dr. Gerberding emphasized the importance
of improving communication with the public, as regards the need for
flu immunization both in general and across the full flu season. Today’s
vaccine surplus, she said, is partly the result of encouraging lower
risk individuals to forego immunization during the shortage period
and the belief by those individuals that, since they weren’t
vaccinated at the beginning of the flu season, they don’t need
vaccination now.
Dr. Jesse Goodman, Director of the FDA Center
for Biologics Evaluation and Research, also noted the severe problems
of a fragile vaccine market,
difficulties in manufacturing vaccines, costly and highly specialized
manufacturing facilities, unpredictable demand, etc. He emphasized
several steps FDA is taking to avoid the situation that occurred with
flu vaccine this season, including improving and increasing its communication
and interaction with vaccine manufacturers and with foreign regulatory
authorities; participating in public education efforts to encourage
vaccination throughout the entire flu season, so demand will be more
predictable and steady and easier to meet; further activities to try
to stimulate interest among foreign licensed manufacturers to apply
to the FDA for approval of their products for U.S. use; considering
alternative processes for vaccine approval (such as accelerated approval,
with surrogate markers, and post-market studies); and ensuring that
manufacturing facilities are inspected annually or more frequently
as needed. CBER, Dr. Goodman stated, is conducting a “vulnerability
analysis” of foreign manufacturing of U.S.-licensed vaccine products,
to try to ensure an “early warning” that a manufacturing
failure could jeopardize supply. He also reported that HHS has issued
two Requests for Proposals designed to secure increased availability
of raw materials and improve manufacturing capacity. Finally, he noted
that HHS intends to spend $439 million on flu-related activities in
FY ’06, nearly $400 million more than last year.
Witnesses from the
Association of State and Territorial Health Officials (Dr. Fay Boozman),
George Washington University Department of Medicine
(Dr. Allan Wasserman), Emory Vaccine Center (Dr. Walter Orenstein),
and the Virginia Department of Health (Dr. Robert Stroube) agreed that
better public communication is needed to encourage vaccination and
that manufacturer incentives are needed to increase the number of companies
willing to stay in, or enter, the vaccine market.
During questioning
of these witnesses, Rep. Henry Waxman (D-CA) asked whether a “guaranteed
market” wouldn’t be a powerful
incentive, and whether the witnesses would encourage the development
of a “vaccines for adults” program, similar to the existing
vaccines for children program (the witnesses agreed). He also noted
that any such program should be broad enough to include all vaccines
recommended for adults.
To reinforce the message
of public education and encouraging flu vaccination, the Committee
sponsored, with GW
University, an immunization “clinic” for
members, staff, and the public, after the hearing.
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Medical
Liability Reform Takes Center Stage in Energy
and Commerce Hearing
On February 10, the
House Energy and Commerce Subcommittee on Health held a hearing on “Current
Issues Related to Medical Liability Reform.” The fifteen-person
panel testifying before the committee represented physicians, legal
scholars, insurance experts and individuals
who have lost loved ones. Newly appointed Subcommittee Chair Rep. Nathan
Deal (R-GA) headed the hearing. While a substantial portion of the
testimony focused on the insurance industry, a number of witnesses
attacked the pharmaceutical industry and the FDA, while legal scholars
spoke in favor of limiting industry liability for punitive damages.
Emotional testimony
was given by Monty Huggins about his wife’s
alleged death from Vioxx. He said that the “FDA is doing a lousy
job.” Huggins noted that right now companies are being
given a “free ride” and that they need to be “held
accountable.”
Dr. Joseph P. Glenmullen
M.D., a psychiatrist at Harvard Law School’s
Mental Health–Law School Health Services, criticized the FDA’s
handling of anti-depressants. He stated both FDA and the pharmaceutical
industry knew a decade ago of potential problems with anti-depressant
drugs, but failed to act. Glenmullen argued limiting lawsuits
against the pharmaceutical industry would leave the U.S. without an
avenue to protect the public. Criticizing FDA for still not doing
enough to ensure safety, he added the agency is still allowing off-label
antidepressant use for children despite information provided by doctors
on side effects.
The general question
posed by Dr. Gurkirpal Singh, Stanford University, was whether
FDA can be relied upon. He noted clinical trials
are designed to show efficacy, not safety. Therefore, studies are likely
to miss safety issues. Post-approval studies are needed, but currently
these are often not followed through. He further noted the current
system is designed for rapid approval. Singh advocated for a mechanism
to allow conditional or time-limited approval and for FDA to provide
the public with more information on drugs.
Lawyer Richard Kingham,
Covington & Burling,
focused on limiting punitive damages for FDA-approved products. He
said proposed legislation
provides a very limited defense for pharmaceutical manufactures
which would apply only to punitive damages, and not economic or pain
and suffering. Punitive damages are meant to apply in cases of “egregious
misconduct,” therefore, if companies provide FDA with all necessary
information, a company should not be held liable. He said
the
approval
of every
drug is a benefit/risk judgment and there is no evidence FDA
is engaging in egregious misconduct. While there are ways to
improve the FDA and the pharmaceutical industry, there is no evidence
of misbehavior to warrant punitive damages
against the pharmaceutical industry.
Dr. Sidney Wolfe, Public
Citizen, disagreed that it should be implied that the FDA is doing
a good job. He quoted
surveys by Public Citizen showing that FDA doctors believe
the standards for safety and efficacy have become lower in recent
years
and
have felt silenced or uncomfortable expressing their opinions.
Victor E. Schwartz,
attorney from Shook, Hardy & Bacon focused
on the purpose of punitive damages – to punish people who have
done something wrong. If companies follow FDA rules,
they have not done anything wrong and should not be punished. He added
if the FDA requires companies to report research to prevent being punished,
this would create an incentive to comply.
Democrats criticized
the pharmaceutical industry, with ranking member Rep. Sherrod Brown
(D-OH) leading the charge. He criticized special interest
groups, including the pharmaceutical industry and medical device manufacturers,
for placing a choke hold on real reform. However, he said he will
not let these industries “cash in on this gravy train” or “dodge
responsibility.” Brown added liability reform legislation
will not pass because it absolves the drug industry. Rep. Lois Capps
(D-CA) said the Republicans have given no evidence for the
need to protect drug companies. Rep. John
Dingell (D-MI) noted FDA by itself can not be relied upon
to make sure medications are properly labeled.
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Specter
Will Remain at Health Appropriations Helm
Sen. Arlen Specter
(R-PA) will remain chair of the Senate Appropriations Subcommittee
on Labor, Health and Human Services and Education.
Rumblings of a potential move to the newly created Appropriations
Subcommittee on Intelligence were quashed this week when, writing
in the Washington Post, Specter highlighted the importance of
continuing his work on health care and other issues.
President
Bush’s
recently released FY2006 budget, Specter said, places critical funding
for the National Institutes
of Health at risk. In his statement
Specter recognized the enormous deficits the U.S. is currently facing.
However, he asserted that Appropriators have not sufficiently recognized
that health care is a capital investment. “[Senator Tom Harkin (D-IA) and I] have more than doubled funding
for NIH, which has made enormous progress on working toward cures for
Parkinson's, Alzheimer's, cancer, heart disease and other deadly or
debilitating diseases,” Specter said. “Those gains may
be nullified unless increases in funding continue.”
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Dust
Settles on Energy and Commerce Membership Shuffle
The House Committee on Energy and Commerce has
both added new members and changed Subcommittee chairs on the Health
and Oversight and Investigations
(O&I) Subcommittees. These Subcommittees can be expected to be
involved in a number of key health-related issues this Congress, including
drug safety and other FDA matters, medical malpractice, Medicaid reform,
Medicare payment and cost issues, vaccine and immunization policy,
etc.
Rep. Nathan Deal (R-GA)
has replaced Mike Bilirakis (R-FL) as chair of the Health Subcommittee
(Representative Bilirakis remains
a member of the Subcommittee); Representative Sherrod Brown (D-OH)
continues as ranking minority member. The Subcommittee roster now
includes 18 Republicans (including Sue Myrick (NC), Mary Bono (D-CA),
and Michael Burgess (TX)) and 15 Democrats (including Tammy Baldwin
(WI)).
The Oversight and Investigations Subcommittee will be chaired by Representative
Ed Whitfield (R-KY), with ranking minority member Bart Stupak (D-MI).
Other Subcommittee members are Republicans Cliff Stearns (FL), Chip
Pickering (MS), Charlie Bass (NH), Greg Walden (OR), Mike Ferguson
(NJ), Michael Burgess (TX), and Marsha Blackburn (TN) and Democrats
Diana DeGette (CO), Jan Schakowsky (IL), Jay Inslee (WA), Tammy Baldwin
(WI), and Henry Waxman (CA).
The new Health Subcommittee had its maiden voyage
into troubled waters with a contentious hearing on Thursday, February
10, on medical malpractice
reform (including the so-called “FDA defense”) (see related
story). The O & I Subcommittee is reported to be looking into,
among other things, drug safety. This is an issue that has been of
enormous concern to Representative Stupak for several years, and he
can be expected to be closely involved in it.
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Debate
Over
Appropriations Subcommittee Changes Continues
The Senate is continuing
to resist change to their current Appropriations subcommittee structure,
while House Appropriations
Chair Jerry Lewis (R-CA) is poised to move ahead with a reorganization
that will reduce the number of subcommittees from 13 to 10.
Earlier in the week,
Senate Appropriations Chair Thad Cochran (R-MS) met with Lewis
to negotiate key differences in their plans. According to sources,
Cochran proposed putting NASA
accounts into the Commerce-Justice-State spending bill, instead of
the Energy and Water measure.
Then on Thursday, Senate
Military Construction Appropriations Subcommittee Chair Kay Bailey
Hutchison (R-TX) proposed a restructuring that would
ensure she maintain her own chair by establishing a new 13-subcommittee
structure that would match up the House's 10 new subcommittees. Hutchison's
proposal is reported to keep the Veterans Affairs and Housing and Urban
Development Departments together, as in the current VA-HUD structure,
but split off science programs, including NASA, into a new subcommittee.
Criticism of House
Majority Leader Tom DeLay’s hand in this
change continues. DeLay, a proponent of increased NASA funding, is
said to have been behind the centerpiece of Lewis’s plan – the
elimination of the VA-HUD subcommittee, which would mean NASA and NSF
would be funded as part of the Energy & Water spending bill. A
spokesman for Subcommittee Chairman Kit Bond (R-MO) called
Hutchison’s proposal "Tom DeLay-lite," a reference
to the feeling among some that the House Majority Leader is driving
the reorganization process to protect NASA funding.
As this week’s
negotiations continued, Senate Appropriators remained resistant to
the plan. If the House
moves ahead with the proposed
changes while leaving the Senate behind, a year-end omnibus spending
bill is practically guaranteed.
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Major
Battle Looming Over Farm Payment Limits
The Bush White House
proposal to limit individual farm program payments to $250,000 (by
tightening eligibility requirements and closing loopholes
critics say allow some producers to reap millions of dollars from federal
programs) faces major opposition from farm groups
who say the net effect of the cap will be to drive family farmers
off their land especially
in the South.
President Bush told
a Detroit Economic Club audience this week limiting farm payments
will
save
the federal treasury $1.2 billion
over 10 years,
a move necessary “to regain the trust of the American people.” But
southern producers, particularly rice and cotton farmers, say capping
payments will cut into their income because their crops cost more to
grow than wheat, corn and soybean crops in the Midwest.
The current payment limit is $360,000 – with
options available to producers to increase that amount dramatically,
negotiated up during
the 2002 Farm Bill conference committee action from the original $250,000
approved by both chambers. One loophole the Administration seeks to
close allows producers to take out loans against crops and repay the
loans below market cost.
Powerful southerners
control key Senate committees in this battle. Sen. Saxby Chambliss
(R-GA) chairs the Senate Agriculture
Committee
and Sen. Thad Cochran (R-MS), former Agriculture Committee chair, now
heads the Senate Appropriations Committee. Both Chambliss and
Cochran
say
the proposed Bush cuts unfairly hit the South while leaving other areas
of the country untouched. Chambliss said it’s unfair to cut crop
payments without reducing conservation program payments used heavily
in the northern half of the country.
Further fueling this
North v. South farm payment battle is that Sen. Chuck Grassley (R-IA),
chair of the Senate Finance
Committee and member
of the agriculture panel, has long fought to limit individual farmer
payments. “They’re (the White House) looking for ways to
save money and this is one of the most intellectually honest ways to
save money,” Grassley said this week.
And while Grassley
and his supporters may try to circumvent Chambliss and Cochran by
pushing their proposals through the Senate Budget Committee,
chaired by farm program critic Sen. Judd Gregg (R-NH), the overriding
fear in the House is that to engage now in the war of payment limits
during the FY2006 budget process means reopening the 2002 Farm Bill
18
months before real action is contemplated.
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"Disaster
Program Must Cover Quality Losses," Say ND Delegation
"The
farm disaster bill passed by Congress last October must be implemented
so that crop quality losses will be covered by the farmer payment
component of the program,” said North Dakota’s congressional
delegation in a letter this week to USDA.
Sens. Byron Dorgan
(D-ND) and Kent Conrad (D-ND)
and Rep. Earl Pomeroy (D-ND) told Deputy Undersecretary for Farm
and Foreign Agriculture
Services Floyd Gaibler USDA should allow local Farm Service Agency
(FSA) committees to create their own quality loss tables that
will reflect regional variations in quality loss. To use a more rigid
national-average calculation would mean some North Dakota farmers
might receive no payment.
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Canada
Border Fracas Continues as USDA Moves to Tweak Import Rule
The
war of words over whether the U.S. should move forward to reopen the
Canadian-U.S. border to live animal trade continued this week in
the wake of an announcement by Secretary of Agriculture Mike Johanns
that USDA will delay a portion of the pending minimal risk area rulemaking
allowing meat from animals over 30 months old to enter the country.
Ten Democratic Senators
introduced a resolution of disapproval to block the USDA rulemaking,
but they need 30 sponsors to get the
measure to the floor. Even if it passes both chambers, the President
would need to sign it. In a related move, the House Agriculture Committee
announced this week it will hold a hearing March 2 to review the USDA
rulemaking on Canadian live animal and meat imports. The Senate agriculture
panel held a hearing two weeks ago.
Johanns said because the U.S./Canadian
BSE investigation spawned by the latest Canadian case is not complete,
it would be
prudent to delay
the import of meat processed from older animals. It would also limit
critics who contend it’s unfair to allow meat from older animals
to enter the country, but not allow older animals to be shipped to
the U.S. for slaughter.
Live feeder cattle
under 30 months old and meat – both boneless
and bone-in cuts – from younger animals are set to begin moving
March 7 under the USDA rulemaking. Canadian media report that 70 percent
of Canada’s
live cattle will be eligible for export under the rulemaking. NCBA
estimates 900,000 animals would move during 2005.
Johanns and Canadian Agriculture Minister
Andrew Mitchell met this week and issued individual and joint statements
about the decision.
Mitchell, who also met with congressional leaders, was pleased with
the USDA action, fearing the department might have pulled back the
entire rulemaking under heavy Capitol Hill and producer group pressure.
The two ag leaders said they also agreed “facts not politics” would
guide border decisions, and decisions will be made on the “latest
scientific information.”
The Canadian Beef Export
Federation called the decision “discouraging
and verging on offensive,” adding the decision was made to placate
the National Cattlemen’s Beef Association (NCBA), which pushed
hard for a delay on meat from animals over 30 months.
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Japan
Okays Cattle Age System, Warns Beef Trade May Not Resume Soon
The glee that greeted an agreement
this week by the Japanese government on a system to determine
cattle age without birth record – the
main stumbling block to resuming U.S./Japan beef trade – was
immediately tempered when the Japanese said no trade will resume until
it’s completed its domestic rulemaking process so import rules
are not more relaxed than domestic programs.
The Japanese Ministries of Agriculture and
Health both signed off on a plan that is similar to one used by
USDA inspectors when grading
beef. Under this system, inspectors visually examine carcasses and
closely inspect teeth, bones and cartilage to determine grading quality.
The U.S. apparently convinced the Japanese any beef rated A40 or lower
was “without exception” from an animal 12-17 months old.
Any beef from animals 20 months of age or older is prohibited from
export to Japan under the current agreement.
However, Japan explained it cannot open its
borders until it has revised and implemented new domestic beef regulations
and Japan has
no deadline for completing the steps that would allow the new domestic
procedures to begin operating. The specific parts of its domestic
program that must change are the rules for BSE testing of domestic
cattle and the rules for imported beef products. As part of that process,
a risk analysis – not yet completed – is underway and
will require public comment before finalized.
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Senators
Seek
to Clarify Rules on Ag Exports to Cuba
A bipartisan group
of 20 Senators, primarily from farm states, this week introduced
a bill to remove the “bureaucratic roadblocks” erected
by the Bush Administration to growing ag trade with Cuba. Cuba is
now the U.S.’s 21st largest trading partner.
The action will clarify
the rules for Cuba trade promulgated after Congress approved a bill
in 2000 allowing agricultural trade with Cuba despite
the formal U.S. embargo of that Caribbean island nation. The Administration
has successfully blocked subsequent attempts by Congress to further
liberalize general trade with Cuba.
Not only is the Administration misinterpreting the Cuba trade law,
the senators said, it is withholding payments from U.S. exporters
and delaying the issuance of export and travel licenses. The Administration
said it is financial institutions, unsure about the law, who are holding
up payments to exporters.
The bill will clarify
that “cash in advance” means
the receipt of payment before release of physical control of goods
to
the purchaser, allow general licenses for U.S. ag producers that
would allow travel to Cuba for the purposes of selling goods, and
authorize Cuban buyers to may payments to America banks.
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Senate
Approves Class-Action Reform Bill
Rejecting
a handful of Democratic amendments, the full Senate this week
approved a compromise
package of reforms to the nation’s
class-action lawsuit rules, handing President Bush his first victory
on legal reforms. The House is expected to take up the bill next week
and is expected to approve it without amendments.
The bill
will move many multi-state class action suits from
state courts to federal
courts where stricter rules apply. This also would
serve to limit "forum shopping" by plaintiffs' attorneys,
where lawyers look to file cases in the "friendliest" state venue.
The compromise
package was fashioned to avoid a contentious conference with a
previously
passed House version of the legislation. Senate
Judiciary Committee Chair Sen. Arlen Specter (R-PA) said the House
bill would not have “passed muster” with the Senate, including
one provision that would have applied the reforms retroactively, upsetting
a number of pending cases.
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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.328
Sen. Larry Craig (R-ID) introduced a bill to clarify the rules for Cuba trade.
S.334
The “Pharmaceutical Market Access and Drug Safety Act” introduced
by Sen. Byron Dorgan (D-ND) would allow for the importation of prescription drugs.
S.338
Sen. Gordon H. Smith (R-OR) introduced a bill to establish a Bipartisan
Commission on Medicaid.
S.345
Sen. Richard Durbin (D-IL) introduced the "Medicare Prescription Drug Savings
and Choice Act of 2005."
H.R.628
A bill introduced by Rep. Rahm Emanuel (D-IL) would provide for an
influenza vaccine awareness campaign, ensure a sufficient influenza
vaccine supply, prepare for an influenza pandemic or epidemic, and
amend the IRS Code to encourage vaccine production capacity.
H.R.650
Rep. Ric Keller (R-FL) offered a bill that would make legal reforms
in order to facilitate the manufacture of vaccines.
H.R.658
Rep. Joseph Pitts (R-PA) introduced a bill to amend the IRS Code to
exclude from gross income gain on the sale or exchange of farmland
development
rights.
H.R.676
A bill introduced by Rep. John Conyers (D-MI) would provide for comprehensive
health insurance coverage for all U.S. residents.
H.R.700
Rep. Jo Ann Emerson (R-MO) offered a bill that would allow for the
importation of prescription drugs.
H.R.713
Legislation introduced by Rep. Ron Lewis (R-KY)
would allow small businesses in rural areas to deduct homeland
security
costs.
H.R.721
Rep. Randy Neugebauer (R-TX) introduced a bill to require the Federal
Crop Insurance Corporation to offer farmers supplemental crop insurance
based on an area yield and loss plan of insurance.
H.R.729
Rep. Pete Stark (D-CA) offered a bill to provide the Secretary of HHS
with the power to negotiate drug prices if the costs of the new Medicare
Part D drug benefit are estimated to exceed the original CBO estimate.
H.R.747
Reps. Charlie Gonzalez (D-TX) and John McHugh (R-NY) introduced legislation to
encourage
healthcare providers to adopt
interoperable health information technologies.
H.R.752
Rep.
Marion Berry (D-AR) introduced legislation to create a nationwide
Medicare prescription drug plan and and give the HHS Secretary
the authority to negotiate drug prices.
H.R.753
A bill introduced by Rep. Jeb Bradley (R-NH) addresses drug importation and counterfeit
prescription drugs.
H.R.765
Legislation by Rep. Mark Kennedy (D-MN) would provide a tax credit for the purchase
of private health insurance and establish State health insurance safety-net
programs.
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Inside
Track is produced as a service to clients of Policy Directions,
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communications firm founded in 1995, specializing in customized
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