House Passes Class Action Bill, Sends to President
Handing President Bush his first major legislative
victory in the 109th Congress, the House this week easily passed the
class-action
reform bill, and supporters now contend this will clear some hurdles
to passage of other litigation-related legislation.
The class action bill
moves multistate class action lawsuits into federal court, which
holds such filings to much stricter standards.
The aim is to curb so-called "frivolous lawsuits" and “forum
shopping” by
plaintiffs’ attorneys. Opponents said the legislation will make
it tougher to sue corporations.
Legislation on asbestos
and medical malpractice reforms were cited by business groups supporting
the class action measure as next up in
the broad battle for tort reform, though both sides of these issues
agree these bills will be much more difficult to get through Congress.
Return to top
Ag Budget Battle Heats Up
“The realization was that very large sums of money were going
to a very few and that controversy is what the president is zeroing
in on,” said Agriculture Secretary Mike Johanns this week in
defending the President’s proposed FY2006 budget cuts, explaining
large farming operations are taking too big a slice of the farm program
payment pie.
The president’s
proposed cap on farm payments -- $250,000 versus the current $350,000 – is
becoming the rallying point in the budget battles. When coupled with
the White House push for an across-the-board
5 percent cut in all farm programs, the battle lines are drawn.
The American Farm Bureau Federation has vowed to fight the budget
proposals with all the tools it has, and is at the top of the list
of over 100 farm, consumer and watchdog groups who are lining up bipartisan
Capitol Hill support to hold the line on farm program cuts.
House Agriculture Committee
Chair Bob Goodlatte (R-VA) and ranking member Rep. Collin Peterson
(D-MN)
sent the House Budget Committee
a letter this week, saying “leave the 2002 Farm Bill alone” until
provisions expire in 2007. And House Agriculture Appropriations Subcommittee
Chair Henry Bonilla (R-TX), during testimony this week from Johanns
on USDA’s budget request, pushed the secretary to name the “winners
and losers” in the budget process. Johanns said no area of agriculture
would be immune to the budget axe. Subcommittee member Rep. Ray LaHood
(R-IL) said the Administration is trying to balance the budget on
the backs of farmers.
USDA Chief Economist Keith Collins
told the Agriculture Appropriations Subcommittee that both farm equity
and income have set records, but
noted farm payments accounted for $15 billion of the net $78 billion
in cash income during 2004. Those payments are expected to balloon
to $24 billion while total income remains the same, Collins said, acknowledging
since southern crop producers receive the highest payments relative
to the value of their crops, southern farmers will “contribute
more” to the budget savings.
On the Senate side,
the National Taxpayers Union (NTU) endorsed comprehensive legislation
by Sen. Chuck Grassley
(R-IA) to cap direct payments to
farmers. Grassley’s legislation – themes of which he said
are “embraced” by the Administration – would cap
payments at $250,000, and would also address a “measurable standard” by
which only true farmers get subsidies; address the three-entity rule
to avoid fraud by allowing farms to subdivide into three separate operations,
and eliminate generic certificates through the limitation of non-recourse
farm loans.
Return to top
House, Senate Introduce Resolutions on USDA
Canadian Border Rule; Report Hits USDA for "Errors" on Meat Imports
“Resolutions of disapproval” have been introduced in both
the House and Senate, the first step in the congressional process of
reviewing and possibly stopping the USDA rulemaking on BSE “minimal
risk” countries that would allow some live cattle to be exported
to the U.S. beginning March 7.
The resolutions are part of a congressional oversight process that
allows debate and decisions over the wisdom of federal agency rulemaking.
If both chambers find the USDA rule to be onerous or overreaching,
they can vote to order the department to rescind the rulemaking. However,
the congressional action requires the President to concur to take effect,
and the likelihood President Bush would go along with the move to rescind
is unlikely given his public statements and commitments to the Canadian
government.
In signing on the Senate
version of the resolution, Sen. Conrad Burns (R-MT), one of the most
vocal critics of the USDA
rulemaking, said, “I’ve
said all along we needed to slow this process down.” He applauded
Secretary of Agriculture Mike Johanns’ agreement this month to
remove from the rulemaking meat from animals over 30 months old. Burns
said he was also concerned that the USDA/FDA team that went to Canada
to participate in that nation’s audit of its feed rule had not
yet filed its report.
Sen. Kent Conrad (D-ND)
said this week a procedural “misstep” by
USDA may thwart the agency’s own rulemaking. Conrad said the
department failed to notify the Senate of its trade regulation, allowing
Congress to review and overrule USDA. A USDA spokesperson said, “As
far as the department is concerned, we submitted it properly. We consider
March 7 to still be the effective date.” USDA routinely files
required Senate reports with the Office of the Vice President,
titular head of the Senate. However, media reports indicated that while
there are references to the rulemaking in the House, there is no reference
in the Senate.
R-CALF has filed legal action against the USDA rulemaking, and this
week, the attorneys general from seven states filed arguments in federal
court supporting the R-CALF action. Joining in the filing were the
attorneys general of Montana, North Dakota, South Dakota, New Mexico,
West Virginia, Connecticut, and Nevada.
In Canada, officials announced the completion
of the government investigation into the January 11 case of BSE,
with all animals tested found negative
for BSE. At the same time, the government found the infected animals’ two
most recent offspring – one was slaughtered and the other was
put down.
In a related development,
USDA’s
Office of Inspector General reported this week that lax oversight
by USDA
allowed 42,000 pounds of
Canadian beef to enter the U.S. in violation of government policy on
imports. The report analyzed how USDA handled imports between August
2003 and April 2004, and found that meat inspectors were confused
by public department announcements and product they were instructed
to allow in to the U.S.
Return to top
Crawford Gets White House Nod
to be FDA Commissioner
Dr. Lester Crawford,
currently acting FDA commissioner, has been nominated by President
Bush to head the federal agency. President
Bush previously wanted to nominate Crawford to the post during
his first term, but was blocked by opposition on the Senate Committee
on Health, Education, Labor & Pensions.
Crawford, well known to industry, previously
served as deputy commissioner of FDA in the Bush Administration.
In previous administrations, Crawford
has served as administration of USDA’s Food Safety & Inspection
Service (FSIS), as well as FDA’s Center for Veterinary Medicine
(CVM). He was director of the Center for Food & Nutrition Policy
at Georgetown University, and has been an advisor to the World Health
Organization for 20 years.
Return to top
HELP Committee Begins Look at
Rx Importation
The Senate Committee on Health, Education, Labor, and Pensions held
two hearings on prescription drug importation this week, the first
focusing on product safety and related issues that had been examined
by a Medicare Modernization Act mandated task force headed by Surgeon
General Dr. Richard Carmona.
The Surgeon General’s testimony, essentially identical to
testimony he presented to the Senate Aging Committee earlier, summarized
the task force findings. The conclusions included that prescription
drug importation raises real and significant safety questions and that
there is not strong
evidence to support windfall-type cost savings. Carmona also stated
while he does not rule out the possibility that safeguards and
enforcement mechanisms could be put in place that might allow for commercial
importation, such safeguards would be numerous and costly.
Also testifying at the hearing were Minnesota Governor
Tim Pawlenty, who described a system put in place for Minnesota citizens
allowing
the importation of prescription products from certain Canadian pharmacies.
Pawlenty stated the Minnesota “experiment” is
working well, though he did acknowledge FDA has taken actions
against some shipments, seizing products as illegal. FDA also has stated
the entire Minnesota system is operating contrary to U.S. law.
Healthcare Distribution Management Association (HDMA) head John Gray
testified about the crucial role pharmaceutical product distributors
play in both ensuring timely access to products for patients and in
maintaining the security of drug supply chain. Gray pointed out
that in some other countries, the majority of the prescription drugs
are counterfeits; unless the U.S. system remains strong and vigilant,
products from these countries will increasingly enter this country.
He noted track-and-trace technology is a promising approach to
security, but there are many hurdles to full adoption of technology
in this.
Carmen Catizone, executive director of the National Association of
Boards of Pharmacy (NABP), reiterated the NABP resolution, presented
to the Surgeon General’s Task Force, that the organization “continue
to oppose the illegal importation of medications and express to the
Food and Drug Administration (FDA) the concerns of its member boards
and strongly urge the FDA or appropriate legal authority to pursue
actions against state and local governments for endorsing, promoting,
or engaging in the illegal importation of medications.” Catizone
described the NABP VIPPS (Verified Internet Pharmacy Practice Sites)
program, by which Internet pharmacies may receive certification and
bear the VIPPS seal, alerting consumers these sites are “legit.” Finally,
Catizone stated essential to safe importation would be is
to ensure only FDA-approved products manufactured in FDA-registered
facilities are allowed, and to ensure appropriate licensing of foreign
distributors.
Dr. Peter Rost, employed in a marketing division of Pfizer but not
speaking for the company, testified he believes importation can
be done safely, based on the parallel trade of pharmaceutical products
throughout the European Union. (Key experts differ on this point,
including the Surgeon General’s Task Force, which found the analogy
flawed. European parallel trade, the task force said, may be
akin to pharmaceutical products moving around the U.S., from state
to state, but is not a sound analogy to importation.)
The second day of the committee’s hearings took testimony from
the Department of Commerce, regarding its study (also mandated by the
MMS) “Pharmaceutical Price Controls in OECD Countries: Implications
for U.S. Consumers, Pricing, Research and Development and Innovation.” The
report found that both price controls are widespread across the countries
(importation proponents on Capitol Hill have been known to argue
there are no price controls, only “tough negotiation”)
and were there not such price controls, there almost certainly
would be a higher level of research and development in those countries
than there is now. The report concluded free market pricing system
for pharmaceutical products in the U.S. is good for U.S. patients because
economic incentives foster investment in the life sciences and in the
development of products that improve health.
Kevin Outterson, associate professor of law at West Virginia University
law school, calling the Commerce Department Study a “flawed discussion,” stated
his view that importation of prescription drugs would result in substantial
savings for consumers (he opined “several billion dollars”)
and would have no impact on pharmaceutical R&D. He did acknowledge,
however, that “public data” are not available to make the
economic assessments accurately, and called for an independent analysis
by an organization (presumably unlike the Commerce Department) that
could evaluate the questions.
Other witnesses at his hearing differed with Outterson and supported
the notion that importation is a flawed policy from an economic perspective.
Dr. Robert Goldberg, Manhattan Institute, argued about the negative
impact the importation of foreign-imposed price controls would have
on progress in biotechnology innovation; Dr. Benjamin Zycher, Pacific
Research Institute for Public Policy, San Francisco, stated U.S.
consumers would be served best by policies that would end the so-called “free-riding” of
other nations on U.S. worldwide pharmaceutical R&D; and Stephen
Pollard, senior fellow and director of health policy, Centre for the
New Europe, Brussels, stated European patients suffer because
of both price controls and parallel trade. Pollard argued profits
are going to middle-men and not, as in the free-market U.S. pricing
system, to pharmaceutical R&D.
Stay tuned for more on this topic, as the Senate HELP Committee next
turns to a discussion of legislation, including the legislation introduced
by Senator Byron Dorgan and sponsored by, among others, ranking HELP
Democrat, Senator Edward Kennedy.
Return to top
Davis, Waxman, Coleman, Feinstein
Introduce Internet Pharmacy Bill
On February 16, Reps. Tom Davis (R-VA) and Henry Waxman (D-CA) and
Sens. Norm Coleman (R-MN) and Dianne Feinstein (D-CA) introduced the
Ryan Haight Internet Pharmacy Consumer Protection Act (H.R. 840 and
S. 399, respectively). The bills are named after a teen-ager who died
after taking an overdose of Vicodin obtained without a prescription
from an Internet pharmacy.
The legislation, which amends the Food, Drug, Cosmetic
Act and is referred to the House Committee on Energy and Commerce and
the Senate
Committee on Health, Education, Labor, and Pensions, would require
Internet pharmacies to provide on their websites information to identify
their pharmacists and physicians, including licensing information,
and information about the business so consumers know where the pharmacy
is located and how to make contact. The legislation also would make
illegal the dispensing of prescription medications without a valid
prescription based on an actual interaction with a physician (not simply
based on an on-line questionnaire) and would provide authority to state
attorneys general to take action against illegally operating web sites
beyond their own jurisdictions.
Sens. Coleman and Feinstein, in their remarks accompanying the bill’s
introduction, cited additional cases of deaths attributed to overdoses
of various Internet-obtained medications, including amitriptyline and
hydrocodone. The Senators stated their bill is supported by the
Federation of State Medical Boards, the National Community Pharmacists
Association, and the American Pharmacists Association, among others.
Reps. Davis and Waxman also noted the support of state
attorneys general and of John Walters, director of the White House
Office of National
Drug Control Policy, who is quoted as saying the legislation “is
an important step in protecting the integrity of our medical system
and in keeping families safe.”
Return to top
FDA Announces New Safety Board
In response to a chorus of concern regarding FDA’s actions related
to drug safety, HHS Secretary Mike Leavitt and FDA Commissioner-designee
Lester Crawford announced on February 15 several specific changes the
agency is taking.
First, a new Drug Safety Oversight Board will be established, comprised
of safety experts from within and outside of FDA, including representatives
of other federal agencies and departments, such as the Department of
Veterans Affairs. The Board is also expected to consult with other
outside experts. While there will be the possibility of consultations
by the Board with FDA medical reviewers, the reviewers will not be
members. According to Leavitt and Crawford the Board will be wholly
independent of the review function, although it will be housed in the
Center for Drug Evaluation and Research.
In addition, the two announced FDA will establish more open channels
of communication with the outside, to “help ensure that established
and emerging drug safety data are quickly available in an easily accessible
form.” One proposal is a new web page, “Drug Watch,” where
information will be posted in language and formats easily usable by
patients, caregivers, and healthcare providers.
Further details about these initiatives have not yet emerged.
Return to top
FDA
Updates Postmarket Commitment Status
In today’s Federal Register, FDA is publishing
a summary status of postmarket commitments, as required by the 1997
Food and Drug Administration
Modernization Act. The Act placed this requirement on FDA in response
to concerns that product sponsors were agreeing to carry out post-market
studies to assure timely product approval, but then were reneging on
the commitment and not obtaining data the agency had indicated was
necessary for the best understanding of a product’s safety and
effectiveness. The post-market commitment status, according to the
publication, is updated annually; this report reflects the status as
of September 30, 2004.
The report provides general statistics only, and not a detailed description
of the studies or names of sponsors. Additional information, absent
confidential commercial data, is available on the FDA web site.
The report indicates, in summary, that of 1191 “open” post-market
studies associated with NDAs or ANDAs (and 288 associated with BLAs),
68% (and 24%) are pending; 18% (and 40%) are ongoing; 1% (and 13%)
are delayed; fewer than 1% (in both cases) have been terminated (ended
before completion, and FDA has not received a study report yet); and
for 12% (and 23%), the study has been completed or terminated and a
report has been submitted.
Of the studies that have been concluded, the post-market commitment
was met in 73% of the cases for both NDA/ANDAs and BLAs. In 27% of
the cases, a determination was made that the study was either not feasible
or was no longer needed. In no case of concluded studies was the post-market
commitment not met.
Finally, the summary indicates that of the open studies, where an
annual report is due, the report has been submitted in the required
timeframe in 84% of the cases for NDA/ANDAs and 34% for BLAs.
Return to top
House Appropriations Committee Settles on
New Structure The House Appropriations Committee this week approved Chair Jerry
Lewis' (R-CA) plan to reduce the number of subcommittees from
13 to 10, and restructure existing
subcommittees. Democrats on the Committee did not support this move and are
reported to have had no input into the changes.
Ranking member, Rep.
David Obey (D-WI) continued his allegations House Majority Leader
Tom DeLay (R-TX) was behind the changes in order to protect
NASA funding, which had been in the VA-HUD bill. A
spokesman for DeLay was quoted as saying that DeLay "has
made it clear the appropriations process wasn't working as well as it could
... and that's
what we're striving for with these changes."
Rep. David L. Hobson (R-OH)
will remain chair of the subcommittee on energy and water development; however
jurisdiction will also
include “related
agencies” such as NASA and NSF.
No decisions have been made on the Senate side and Senate Appropriations Chair
Thad Cochran's (R-MS) continues to face resistance from Republican senators.
Return to top
Specter Continuing Duties While
Undergoing Treatment
Sen. Arlen Specter
(R-PA) announced this week he has been diagnosed with Hodgkin’s
disease, a cancer of the lymph system. He is
expected to receive ABVD chemotherapy every two weeks over the next
24 to 32 weeks at the Abramson Cancer Center in
Philadelphia. Currently, the Senator plans to maintain his duties and
chair of the Judiciary Committee and chair of the Senate Appropriations
subcommittee on labor, health and human services and education.
In a statement, Specter said: “I have beaten a brain tumor,
bypass heart surgery and many tough political opponents; and I’m
going to beat this too. I have a lot more work to do for Pennsylvania
and America.
Return to top
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.J.RES.4
Sen. Kent Conrad (D-ND) offered a joint resolution providing for congressional
disapproval of the recent USDA rule that designates Canada as a minimal-risk
region for bse.
S.382
Sen. John Ensign (R-NV) introduced a bill that would make the transportation
of animals for fighting a felony, establish a penalty of up to
two years in prison and ban the transportation of tools specifically
designed for animal fighting.
S.375
Legislation introduced by Sen. Evan Bayh (D-IN) 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.
S.399
Sens. Norm Coleman (R-MN) and Diane Feinstein (D-CA) introduced a bill
which would create restrictions on the sale of prescription drugs
through the Internet. S.445
Sen. Debbie Stabenow (D-MI) offered a bill to provide the HHS Secretary
with the authority to negotiate drug prices.
H.CON.RES.75
A resolution introduced by Rep. Gregory Meeks (D-NY) expresses
the sense of the Congress that the illegal importation of prescription drugs
severely
undermines the regulatory protections
afforded to U.S. consumers.
H.J.RES.23
Stephanie Herseth (D-ND) offered a joint resolution providing for congressional
disapproval of the recent USDA rule that designates Canada as a minimal-risk
region for bse.
H.R.813
Rep. Rahm Emanuel (D-IL) introduced a bill to 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.817
Legislation introduced by Rep. Mark Green (R-WI) would strengthen prohibitions
against animal fighting by making it a felony to transport animals
and cockfighting paraphernalia across state lines.
H.R.839
Rep. Henry Waxman (D-CA0 offered a bill aimed at protecting scientific
integrity in federal research and policymaking.
H.R. 840
Reps. Tom Davis (R-VA) and Henry Waxman (D-CA) introduced a bill which
would create restrictions on the sale of prescription drugs through
the Internet.
H.R.859
Rep. Collin Peterson (D-MN) offered legislation to extend contracts
for national dairy market loss payments through the end of fiscal year
2007.
H.R.870
Rep. Pete Stark (D-CA) introduced “The Pharmaceutical Research
and Manufacturers Accountability Act” which would create new
enforcement mechanisms in the FDA to impose jail sentences and large
fines on CEOs and other drug company executives for failing to disclose
safety concerns.
H.R.985
Legislation introduced by Reps. Heather
Wilson (R-NM) and Donna Christian-Christensen (D-VI) would establish
a Bipartisan Commission
on
Medicaid.
Return to top
Inside
Track is produced as a service to clients of Policy Directions,
Inc., a Washington, DC-based government relations/strategic government
communications firm founded in 1995, specializing in customized
advocacy on health care; food; biomedical research; biotechnology,
human drug, and medical device regulation; federal nutrition policy
and programs; and environmental policies and programs. For more
information about PDI, please e-mail info@poldir.com.
All material © 2005 Policy Directions.
|
