House Committee Passes Agriculture/FDA
Appropriations
In keeping with House Appropriations Committee Chair Jerry
Lewis’ goal of completing all 13 appropriations bill before August, the
full House this week approved the nearly $17-billion FY2006 discretionary ag/FDA
spending package. By a vote of 408-18, the House passed H.R. 2744,
a bill making FY 2006 appropriations for the Department of Agriculture, the
Food and Drug Administration,
and other agencies.
The bill is $93 million more than in the last fiscal year, and just slightly
above the President’s request. When mandatory program spending is added
to this total, full agriculture/FDA spending in FY2006 will total $82.822 billion.
The Senate begins its subcommittee markup process in late June.
Approps Bill Gives Slight Increases in Agriculture, Suspends
Cool Funding
The bill increases conservation program spending by $26 million over the President’s
request, bringing full funding to $794 million, $37 million less than spent
in FY2005. BSE spending was set at $90 million, in line with the President’s
request.
Included in the bill is language that suspends funding of
mandatory country-of-origin meat labeling (COOL). The National Farmers Union
(NFU) and 122 other groups asked
the House to strike the provision, but were unsuccessful.
The House rejected various other amendments, including one
that would require BSE testing on all animals and byproducts. However, the
full House adopted amendments withholding
funding for inspection and oversight of horse slaughter, an issue pushed by
animal rights groups, as well as another amendment that would prohibit school
lunch poultry purchases if the birds had been treated with flouroquinolones.
Return
to top FDA Issues Fueled Debate
For FDA, the House bill provides approximately $1.84
billion, including approximately:
• $444.1 million for Center for Food Safety & Applied Nutrition
• $519.8 million for Center for Drug Evaluation & Research
• $178.7 million for Center for Biologics Evaluation & Research
• $99.8 million for Center for Veterinary Medicine
• $243.9 million for Center for Devices and Radiological Health
• $305.3 million in prescription drug user fees (PDUFA)
• $40.3 million in device user fees
• $11.3 million in animal drug user fees Among the issues discussed during the House deliberations were several
related to FDA.
Two amendments were offered by Rep. Maurice Hinchey (D-NY). One would
have included provisions to authorize the HHS Secretary (FDA) to require
the manufacturer of an approved drug to conduct studies “to confirm
or refute an empirical or theoretical hypothesis of a significant safety
issue.” Hinchey and several other members said protection
of the public health demands FDA have such authority. They argued
without this authorization, pharmaceutical companies will not conduct
post-market drug safety studies and the public will not receive timely
and accurate information about safety problems.
Reps. Henry Bonilla (R-TX), Chair of the Agriculture
Appropriations subcommittee, raised a point of order that the amendment
would legislate
on an appropriations bill, thus violating House rules. The point of order
was sustained.
A second Hinchey amendment would prohibit use of FDA
funds to “grant
a waiver of a financial conflict of interest requirement under the Federal
Food, Drug, & Cosmetic Act for any voting member of an advisory committee
or panel of the FDA; or to make a certification under existing law for
any such voting member.” Hinchey cited an advisory committee on
breast implants and one on COX-2 inhibitors, both of which, according
to Hinchey, were heavily populated with individuals who had financial
ties to affected companies.
Rep. Tom Latham (R-IA) argued strongly these provisions
are unnecessary and could be harmful. He cited protections currently
in place to assure
FDA outside advisors do not have conflicts preventing them from
providing sound advice to the agency. He also said denying the agency
any possibility of waivers would result in reducing the availability
of expert advice.
The amendment passed on a roll call vote of 218-210.
Rep. Bart Stupak (D-MI) offered two amendments. One
would have prohibited the use of FDA funds “to keep in effect an
exemption under section 505(i)” or to approve an NDA for a drug
for a serious or life-threatening illness if the clinical trial(s) done
under the IND
and/or for the purpose of the NDA are not listed in the NIH-sponsored
clinical trials registry, clinicaltrials.gov. In arguing for his amendment,
Stupak stated he simply intended FDA enforce
existing law. He called current compliance (i.e., listing of trials in
clinicaltrials.gov) “dismal at best.” According to Stupak, “While
80% of drug trials are privately conducted, only 13% of
them are listed on clinicaltrials.gov. FDA analysis from 2002 showed
that less than half of all cancer trials are on the FDA Web site”
A point of order raised against this amendment was sustained.
A second Stupak amendment would have prohibited the
use of FDA funds “to
conduct any investigation of, or take any employment action against,
an officer or employee of [FDA] pursuant to the officer or employee providing
to the Congress or the public information or opinions that concern such
Administration and are not prohibited from disclosure under section 301(j)
of the Federal Food, Drug, & Cosmetic Act.”
Stupak argued
this provision was necessary to protect FDA whistleblowers from what
he described as “secret
investigations” by the
agency. He referred specifically to “recent reports” that
Dr. David Graham was asked to leave his position at the CDER Office
of Drug Safety. According to Graham, he was offered a new FDA position,
heading drug safety activities in the Office of the Commissioner,
which
he declined because he would be inhibited from expressing his concerns
about the agency if he were in such a position. (Graham
testified in fall 2004 at a Senate Finance Committee hearing that
five marketed drugs - which he named - pose great risks and should
be re-evaluated.) Rep. Rosa DeLauro (D-CT)
supported the Stupak amendment, stating “rather
than encouraging employees to speak out and engage in scientific debate,
the FDA has worked hard to silence employees who believe that a drug
on the market is harmful to the health of the American people.”
A point of order was raised against this amendment
and was sustained.
Rep. Dennis Kucinich (D-OH) offered an amendment, also
struck down on a point of order, to prohibit the use of FDA funds to
review
an application
for or approve an animal drug for creating transgenic salmon or
other fish. The House-passed bill also includes a provision added at subcommittee
mark-up to prohibit use of FDA funds “to prevent an individual
not in the business of importing a prescription drug within the meaning
of section 801(g) of such Act, wholesalers, or pharmacists from importing
a prescription drug which complies with sections 501, 502, and 505.”
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House Subcommittee Approves Labor-HHS Approps
The House Appropriations/Labor-HHS Subcommittee approved
a $602 billion bill this week, including approximately:
• $6.1 billion for CDC, $295 million below FY2005
levels and $181 million above the White House’s request
• $28.5 billion for NIH, 145 million over FY 2005 levels and matching the
White House request
• $2.4 billion for HHS bioterrorism programs, an increase of $185 million
over last year
• $75 million for the Health Information Technology initiative program,
$58 million above last year and $3 million more than the White House request
Ranking Member David Obey (D-WI) was the sole dissenting
vote. He said the proposed 0.5% increase for NIH in FY 2006 is the smallest
in 36 years and is 2.6% short of what the agency estimates it will need to
keep up with inflation in research costs.
No amendments were added to the bill. The full Appropriations
Committee is expected to take up the legislation as early as next week.
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NASA & NSF Funding Moving Through Committee
The House Appropriations/Science Subcommittee approved a
$57.45 billion bill, compared to $56.24 billion for last year.
National Aeronautics and Space Administration (NASA) is
funded at $16.5 billion, $275 million above FY2005 and $15 million above
the White
House request. This includes:
•
$3.1 billion for the President’s vision for space exploration
•
$906
million, restoration of the aeronautics research program to the enacted level
•
$40 million over the request to partially restore NASA’s science programs
•
full request for the Space Shuttle program
National Science Foundation (NSF) is funded at $5.64 billion, a $171 million
increase over last year and $38 million above the budget request. This includes:
•
$4.38 billion for research, $157 million over last year
•
$807 million for education and human resources, $70 million above the White
House request
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“Conspiracy of Silence” Report Attacks FDA and
Industry for Post-market Commitment Failures
A report issued by Rep. Ed Markey (D-MA) claims the
pharmaceutical industry is ignoring requirements to conduct post-market
studies and
FDA is not enforcing post-market commitments related to products
approved under the accelerated approval mechanism. Further, the report
claims, companies are remiss in reporting post-market study commitments
to the SEC -- information, according to Markey, important for
shareholders to know.
The report evolved from data provided to Markey’s
staff in response to his inquiry to FDA, along with publicly available
FDA data
on post-market commitments, as well as responses from the SEC.
The report highlights what it terms discrepancies between FDA’s
public reports on the status of post-market studies and the data provided
in response to the Markey inquiry. It states the data analysis indicates
a striking failure on the part of companies to fulfill commitments and
on the part of FDA to enforce them.
In his press statement, Markey said it is especially
important for patients with serious or life-threatening illnesses to
have information
confirming the efficacy of their drug products approved under accelerated
approval. He noted this approval mechanism allows marketing of drugs
before the clinical benefit has been confirmed and failure to conduct
confirmatory studies literally threatens the life of patients.
Data included in the report indicate of 91 required
post-marketing studies, 42 have not been finished and, of these, only
half have been
started. The Markey inquiry to FDA appeared to combine Fast Track and
accelerated approval products, so it is difficult to compare the FDA
and Markey report data to determine the extent of discrepancies, if any.
In responding to Markey, FDA said 19 Fast Track products (of a
total of 38) received accelerated approval and there are 80 accelerated
approval confirmatory studies, for which final reports have been submitted
(i.e., studies were completed) for 48. The Markey report identifies these
apparent discrepancies and has asked FDA to explain them in a subsequent
inquiry.
As to the SEC, the agency responded this is not a black-and-white
issue. Companies are required to disclose, the agency said, “information
regarding the status of a particular post-marketing study commitment
if … investors would find that information to be significant in
assessing an investment in that company.” This, the agency said,
must be decided on a case-by-case basis, in accord with the financial
relevance to a company of a specific product.
Markey indicated his intention to introduce legislation
to require companies to inform patients and doctors that a product has
been
approved under accelerated approval (which he refers to as “conditional” approval);
include labeling to distinguish between accelerated and “regular” approval;
establish penalties for failing to complete required post-market studies
and enhance penalties associated with harm to consumers from products
for which required studies were not completed; specifically authorize
FDA to require post-market studies and label changes; and establish FDA
whistleblower protections.
Trade Agreement Patent Provisions Take Center Stage
Recently activities in the House have focused on provisions in several
trade agreements, including the U.S-Singapore, -Australia, and –Morocco
agreements, as well as the Central America Free Trade Agreement (CAFTA).
Provisions requiring parties to these agreements to protect patent rights
have been described as concessions to the pharmaceutical industry (although
the provisions do not exclusively relate to pharmaceutical patents) and,
in two cases, have become the subject of congressional activity.
Rep. Anne Northup (R-KY) offered an amendment (which
was incorporated in the bill) to the Science, State, Justice, and Commerce
FY 2006 appropriations
bill. The amendment would prohibit the use of funds to “include
in any bilateral or multilateral trade agreement” provisions or
policies on patents like those included in the Australia, Singapore,
or Morocco agreements. The House Appropriations Committee has completed
its consideration of this bill. House floor
action is scheduled for Tuesday, June 14.
On another front, Rep. Henry Waxman (D-CA), as ranking
Democrat on the House Government Reform Committee, released a staff report
highlighting
the view that various trade agreements, including CAFTA, include patent-related
provisions that impede access to critical therapies by patients in developing
countries.
The patent provisions, the report says, delay the approval
of generic drugs in these nations and block two mechanisms countries
use to
make medicines more affordable: compulsory licensing and parallel importation.
The report refers specifically, for example, to trade agreement provisions
requiring specific times for patented products to be on the market;
patent extensions for unreasonable regulatory delays; and patents for
diagnostic, therapeutic, and surgical methods currently exempt from patent
requirements. These provisions, the Waxman report says, are directly
contrary to the public health principles of the Doha Declaration.
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Burton, Defazio Re-Introduce Medical Treatment Access
Bill
On June 8, Reps. Dan Burton (R-IN) and Peter DeFazio (D-OR) introduced
H.R. 2792, the Access to Medical Treatment Act. Legislation identical
with or similar to this bill has previously been introduced numerous
times by these sponsors and others including, in the Senate, Sen. Tom
Harkin (D-IA). The bills aim is to assure that patients are free “to
choose complimentary and alternative medical treatments, prescribed
by their licensed health care practitioners, including treatments which
may not yet have” been approved by FDA.
DeFazio, in a press statement announcing the bill, said that this
kind of legislation is necessary to help reduce the cost of health
care by allowing individuals to choose less costly alternative therapies. “I
want to get the thousand-pound gorilla known as the FDA off the backs
of people … without compromising the public’s safety,” he
said.
The legislation would allow a licensed medical practitioner to prescribe,
dispense, or administer, and a patient to access, any treatment, provided
the administration of the treatment is legal and the practitioner personally
has examined the patient. The legislation also would require informed
consent by the patient and that labeling of any product used in the
treatment not be false or misleading. The legislation would make legal
the use, in treatment, of unapproved drugs and medical devices so long
as the patient is given notice of this fact.
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Crawford Nomination: One Step Forward, Two Steps Back?
The HHS Inspector General (IG), which had been asked by Sen. Mike
Enzi (R-WY), Chair of the Senate Health, Education, Labor & Pensions
Committee (HELP), to investigate anonymous charges against Dr. Lester
Crawford, completed its investigation and reported its findings earlier
this week. The IG reported that, as to several accusations against
Crawford, “our investigation … revealed no evidence to
support a conclusion that Dr. Crawford acted inappropriately.”
After receiving the report, Enzi announced that he intended to move
Crawford’s nomination forward, and the Committee has scheduled
an executive session for 9:30 a.m. June 15 to consider the nomination.
If the nomination is reported favorably it could then move to full
Senate consideration shortly thereafter.
However, in comments to the press, Sens. Hillary Clinton (D-NY),
Patty Murray (D-WA), and Tom Coburn (R-OK) have indicated they will “hold” the
Crawford nomination until and unless their concerns are addressed.
Clinton and Murray are concerned about Plan B, a contraceptive drug
they believe should be available over the counter, and Coburn wants
condoms re-labeled to indicate they do not prevent HPV infection.
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Senate Gears Up
to Bolster Project BioShield; Ag Pushes for Inclusion
A coalition of national feed, livestock producer and animal health groups
is pushing the Senate to include food and agriculture protections and incentives
in any rewrite of Project BioShield law that may evolve this summer.
Agriculture is seeking expedited test development, vaccine and serum development,
and federal stockpiling to prevent and counteract accidental or intentional
introduction of potentially devastating animal and plant diseases, including
foot-and-mouth disease, tuberculosis and BSE. At the same time, remediation
tools are needed once an outbreak is controlled, including a federal stockpile
of disinfectants and other chemical agents to quickly get food production back
to capacity.
Project BioShield legislation was enacted in the last Congress to provide
the U.S. government tools to improve medical countermeasures protecting Americans
against a chemical, biological, radiological or nuclear attack. This legislation
recognized the federal arsenal against bioterrorism is inadequate to protect
the U.S. population.
So far Sens. Bill Frist (R-TN) and Joe Lieberman (D-CT) have introduced bills
to strengthen last year’s Project BioShield action. Frist, in his role
as Senate Majority Leader, has said such legislation is a priority and he’d
like to act this summer on the Senate’s version of amendments. Sen. Richard
Burr (R-NC) announced this week his "vision" for, and an outline
for, draft legislation to increase bioterrorism preparedness. Burr, chair of
the Senate Subcommittee on Bioterrorism & Public Health Preparedness, said
he's working with members on both sides of the aisle and will make BioShield
II a priority of his subcommittee this summer.
Harkin, Lugar Introduce Biobased Fuels, Products Bill
A bill to provide incentives for research and development, demonstration,
commercialization and marketing of biobased fuels and biobased products was
introduced this week by Sens. Tom Harkin (D-IA) and Richard Lugar (R-IN). They
were joined by Sens. Norm Coleman (R-MN) and Barack Obama (D-IL).
The bill would update the Biomass Research & Development Act and increase
its funding by $1 billion; it provides a “reverse auction” of production
incentives for the first one billion gallons of cellulosic biofuels. As production
increases, the incentives would diminish. The bill also creates a new assistant
secretary for energy and bioproduct development at USDA, and expands the bioproduct
procurement requirements of the federal government.
The bill, predicated on national energy security, seeks to develop alternative
fuel and product components to help wean the U.S. from dependence on petroleum.
The bill cites the success of ethanol and biodiesel as “making great
inroads in reducing our foreign oil dependence.” Harkin and Lugar said
a strong Renewable Fuels Standard (RFS) is important to jumpstarting the “bioeconomy.”
Harkin said rural economies would benefit most from his legislation, with
a “mature biomass” industry creating a million jobs and generating
$5 billion in annual revenue for farmers.
CAFTA Opposition Growing; Senate GOP to Meet with Sugar
Interests, USTR Unveils New Labor Protections Proposal
With opposition to the Central America Free Trade Agreement (CAFTA) growing
almost daily, Senate Republicans this week announced they will meet with representatives
of the sugar industry in hopes of brokering a deal to moderate any negative
effects the treaty may have on the sugar industry.
Meanwhile Ambassador Rob Portman, U.S. Special Trade Representative,
said the Administration will embark on a new initiative on CAFTA labor protections
in order to shore up wavering Democratic support for the trade pact. Portman’s
deal will be a lending institution-funded initiative to help CAFTA governments
develop labor standards of their own, including improving their labor ministries,
improving labor courts, and cracking down on discrimination, in particular
gender discrimination. The U.S. will offer to increase funding to help CAFTA
nations build their ability to enforce labor laws, as well as to develop ways
to monitor activity.
Sen. Norm Coleman (R-MN) said the sugar industry meeting he is holding is
an opportunity for Senators to hear from industry about ideas for a compromise
that might lead to industry dropping its opposition. An incentive for the sugar
industry is that it is beginning to be viewed working against those farm interests
which support CAFTA. Groups attending the meeting next week with Coleman and
other GOP senators include American Sugar Refining Co., American Sugar Cane
League, American Crystal Sugar Co., and the American Sugarbeet Growers Assn.
Just before a hearing this week in the Senate Agriculture Committee, Chair
Saxby Chambliss (R-GA) met with sugar interests and asked them to designate
a team to sit down and talk with the White House about how concerns can be
met.
Groups File Against EPA on CAFO Air Quality Compliance
A quartet of environmental and farm activist groups have filed
suit against EPA to nullify the compliance agreement between the agency and
confined animal
feeding operations (CAFO). The Environmental Integrity Project, Sierra Club,
Iowa Citizens for Community Improvement and the Association of Irritated Residents
(AIR), filed suit on May 26 alleging the agreement is a “sweetheart” deal
allowing CAFOs to continue to pollute without fear of penalty. The EPA/CAFO
agreement says it must be demonstrated that a CAFO actually contributes
to pollution to be brought under air quality regulations.
Japan Confirms 20th Case of BSE
The Japanese government this week confirmed it has found the 20th case of
BSE in the Japanese beef herd, less than a week after announcing the 19th case.
The disease was diagnosed in a four year-old Holstein cow in Shikaoi, Hokkaido.
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.1181
Sen. John Cornyn (R-TX) proposed a bill to provide that any future
legislation to establish a new exemption under the Freedom of Information
Act be stated explicitly within the text of the bill.
H.R.2763
A bill introduced by Rep. Lois Capps (D-CA) would authorize the Director
of the Centers for Disease Control & Prevention to make grants
to local educational agencies to support the purchase or lease and
use of vending machines that offer healthy foods and beverages in
schools.
H.R.2795
Rep. Lamar Smith (R-TX) introduced the “Patent Reform Act of
2005.”
H.R.2802
Rep. Eliot Engel (D-NY) offered a bill to prohibit the manufacture,
marketing, sale, or shipment in interstate commerce of products designed
to assist in defrauding a drug test.
H.R.2814
Legislation offered by Rep. Michael McNulty (D-NY) would prohibit Federal
funds from being used for the payment or reimbursement of sexual
or erectile dysfunction drugs for sex offenders.
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