Stem Cell Bill Wins House Support
On Tuesday, “The Stem Cell Research Enhancement Act of 2005,” H.R.
810, passed on the House floor by a vote of 238 to 194. The bi-partisan
bill sponsored by Reps. Mike Castle (R-DE) and Diana DeGette (D-CO)
received 50 Republican votes, including members who pride themselves
on their “pro-life” record. President Bush continues to
threaten a veto, including when he held a press conference the day
of the vote with children who had been adopted as embryos.
Senate Majority Leader Bill Frist (T-TN) said this week that he wanted
to consult with colleagues before bringing the bill up for a vote.
Minority leader Sen. Harry Reid (D-NV) called on the Senate to act
quickly in passing the bill. But even if Frist does not bring up the
measure, Sen. Orrin Hatch (R-UT) said he would force a vote by attaching
it as an amendment to another bill. And at least one opponent of the
measure, Sen. Sam Brownback (R-KS), indicated that if Frist puts the
bill on the agenda, he may try to block it by filibuster. Sen. Arlen
Specter (R-PA) responded to Bush’s veto threat in a press conference
noting 58 senators signed on to a letter in support of stem cell research
last year. This is close to the number that would be needed to over-ride
a veto. (The House bill did not pass with a veto-proof margin.)
H.R.810 specifies that fundable cell lines come from
IVF-created embryos donated by infertile couples who no longer need
the embryos
to have children and would otherwise discard them. Couples would donate
embryos with written informed consent and would not receive any compensation.
At the same time, the House debated and passed H.R.2520,
the “Stem Cell Research and Therapeutic Act.” This legislation,
which passed the House with only one dissenting vote, would require
contracts with cord blood stem cell banks to assist in collecting
and maintaining human cord blood for transplantation. Proponents of
this bill, authored by Rep. Chris Smith (R-NJ) and others,
offered it as an alternative to H.R.810. They argued that there is
considerable scientific evidence of the medical benefit of cord blood
stem cells, while no such evidence exists for embryonic stem cells.
They argued as well that the development of cell lines from cord blood
does not result in the destruction of embryos. The legislation also
reauthorizes the National Bone Marrow Registry.
Return to top
Senate Committee Reports Rx Drug Monitoring Legislation
On May 25, the Senate Committee on Health, Education, Labor & Pensions
(HELP) reported S.518, the “National All Schedules Prescription
Electronic Reporting Act,” sponsored by Sen. Jeff Sessions (R-AL)
and others.
The bill would require the Secretary of HHS to award state grants
to establish or improve controlled substances monitoring programs.
This would include a state establishing an electronic database with
reports from dispensers of prescriptions for controlled substances.
Information from these databases could be provided, on request, to
law enforcement and narcotics control authorities, federal agencies,
and others. The Secretary, in awarding the funds, would establish a
uniform electronic format. Funds would be awarded to states generally
according to a formula based on the number of pharmacies in the state
as compared with the number of pharmacies nationwide. The bill would
authorize $25 million for each of FY 2006 and 2007 and $15 million
for each of the subsequent three years.
The driving force behind this legislation, like similar
legislation introduced in the House (H.R.1132 and H.R.1139) is the
alarming increase
in diversion and abuse of prescription drugs, including oxycontin.
This type of legislation has been supported strongly by Rep. Harold
Rogers (R-KY), who was instrumental in establishing and funding an
electronic Rx monitoring program in Kentucky. In speaking of this program,
Rogers
credits it with reversing a situation in his state he describes as
disastrous, with multiple deaths resulting from misuse and abuse of
oxycontin.
Significant technical and philosophical differences
exist between the House bills and the House and Senate bills that could
be hurdles
to reaching a consensus and moving this kind of legislation to the
President’s desk. Although the House Energy & Commerce Committee
has held hearings on the issue, no action has been taken. It also is
unclear
how quickly the HELP Committee-approved bill will move to the Senate
floor.
Return to top
House Committees Take Up Pro Sports Steroid Legislation
On May 25, the House Energy & Commerce Subcommittee
on Commerce, Trade, & Consumer Protection reported the “Drug
Free Sports Act,” H.R.1862. Introduced by Rep. Cliff Stearns
(R-FL), the bill would require the Secretary of Commerce to promulgate
regulations
requiring professional sports organizations to establish, maintain,
and enforce independent party drug testing of athletes according to
minimum standards. The substances to be tested for, generally steroids,
are defined as those prohibited by the World Anti-Doping Agency and
determined by the Secretary of Commerce, in consultation with FDA,
to be performance-enhancing substances.
The bill would allow exemptions for certain uses of
prohibited substances for legitimate medical purposes, and would require
strong penalties – a
two year suspension for a first violation and a lifetime ban from the
sport for a second. The bill would establish substantial monetary penalties
for any sports association that does not implement these requirements.
Reports to Congress are also required from both the Secretary of Commerce,
regarding the effectiveness of this testing, and from the GAO, regarding
testing of high school and college athletes. The Subcommittee unanimously
ordered the bill reported to the full Committee, which is expected
to take it up shortly after the congressional Memorial Day work period.
On May 26, the House Government Reform Committee unanimously ordered
reported H.R.2565, the “Clean Sports Act,” which also addresses
steroid use by professional athletes. H.R.2565, co-sponsored by Reps.
Tom Davis (R-VA) and Henry Waxman (R-CA), a companion to Sen. John
McCain’s (R-AZ) S.1114, would make it unlawful for a professional
sports organization to organize, produce, or promote a game without
putting into place drug testing programs as strict as those of the
U.S. Anti-Doping Agency.
The Clean Sports Act lays out minimum standards, such
as testing at least five times per year, and penalties similar to those
of H.R.1862. It would authorize the Director of the Office of National
Drug Control Policy to modify the requirements laid out in the bill.
Violation of
these requirements would fall under section 18 of the Federal Trade
Commission (FTC) Act regarding unfair or deceptive acts or practices.
The FTC would be authorized to enforce these provisions, including
authority for increased monetary penalties as compared with those generally
levied for such violations.
Although significant differences exist between the
two bills with regard to the mechanisms of regulation and enforcement,
virtually no differences
exist in the thrusts of the bills – to force professional sports
organizations to strengthen and enforce drug testing programs. Quick
House action on the issue is likely, based on the expeditious and forceful
Committee action in both cases, following on the heels of both Committees
having highly visible hearings on the topic.
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House Appropriations Committee Approves Ag Spending
After Contentious Debate
On Wednesday, the House Appropriations Committee approved a $100 billion
spending bill for FDA, USDA and related agencies - $93 million more
than Bush requested. However, the real fireworks surrounded two failed
FDA proposals.
Rep. Maurice Hinchey (D-NY) introduced an amendment that would have
allowed FDA to require studies once drugs are on the market if the
agency believes that either a drug or drug class may be too dangerous
based on data from a range of organizations or “other sources
as the secretary determines to be appropriate.” The amendment
also called for allowing FDA to require label changes if FDA determines
a label fails to provide adequate safety or efficacy information.
Many Republican members apposed the amendment because it was creating “authorizing” language
on a spending bill. Yet Hinchey and ranking member David Obey (D-WI)
countered that authorizing provisions are often offered, and passed,
by Republican members. The amendment failed 31-to-25.
A separate amendment by Rep. Jack Kingston (R-GA) on “Drug Efficacy
Study Implementation” drugs (DESI drugs) also failed by a voice
vote. Kingston’s amendment would have restricted FDA from withdrawing
drugs that were on the market before efficacy requirements were enacted
in 1962.
Return to top
“Full Funding” to Implement
DSHEA Introduced
On May 19, Reps. Dan Burton (R-IN) and Frank Pallone
(D-NJ) introduced H.R.2485, the “Dietary Supplement Health and
Education Act (DSHEA) Full Implementation and
Enforcement Act.” The bill would authorize $20, 30, 40, 50, and
65 million for each of FY2006-2010 for FDA and $30 million for FY2006
and “such sums as necessary” for
the subsequent four fiscal years, to implement DSHEA provisions.
Among the bills Findings are that more than 158 million consumers
spend more than $17 billion annually to purchase dietary supplement
products, that DSHEA provided FDA with authority to set standards for
good manufacturing of supplements and to remove unsafe products from
the market, and that FDA has not adequately exercised this authority.
The Findings acknowledge that one of the reasons for FDA’s lack
of activity is that the agency has had insufficient resources; the
bill is intended to remedy that problem.
On the same day, Pallone introduced H.R.2510, which
is identical with H.R.2485 in provisions relating to the authorization
of funds,
but includes several additional items. H.R.2485 requires the Secretary
of Health and Human Services through the FDA to establish a system
for the reporting of adverse events related to the use of dietary supplements;
authorizes appropriations for programs to educate consumers and health
care providers about the benefits and safety of supplements, and requires
a detailed annual report to Congress (beginning January 2007) on the
implementation and enforcement of DSHEA.
Finally, the bill includes a Sense of Congress that, if the Secretary
finds that a supplement containing ephedrine alkaloids presents a significant
or unreasonable risk of illness or injury, all supplements with those
ingredients should be taken off the market. A second Sense of the Congress
urges the Secretary to ensure that botanical sources of ephedrine alkaloids
should remain available if they have not been chemically altered or
manipulated, are marketed at dosage levels used in traditional herbal
formulas, and are labeled only for traditional uses (not for weight
loss or energy).
Return to top
Congress Responds to Medicaid Coverage of ED Drugs Responding to reports that Medicaid had paid, in several states, for
erectile dysfunction (ED) drugs for released or paroled criminals who
had been convicted of sex crimes, Sen. Chuck Grassley (R-IA) and three
cosponsors introduced S.1113 on May 24 and Sens. Chuck Schumer (D-NY)
and Hillary Clinton (D-NY) introduced S.1126 on May 25. The bills prohibit
the expenditure of federal funds to pay for ED drugs. S.1113 prohibits
payment or reimbursement for any patient, including individuals convicted
of crimes relating to sexual abuse, assault, etc., while the Schumer-Clinton
bill applies only to convicted criminals. Both bills would prohibit
payment or reimbursement in any federal program, including Medicaid,
VA, Department of Defense, Indian Health Service, Public Health Service,
and the Federal Employees’ Health Benefits insurance. On May
26, Rep. Vito Fossella (R-NY) and eight cosponsors introduced H.R.2648,
to require Medicaid drug utilization review programs to deny coverage
of ED drugs for sex offenders.
The Centers for Medicare and Medicaid Services already
had taken steps following these reports, stating that Medicaid payment
for such drugs
for convicted criminals represented an “oversight” in state
Medicaid payment policies. On May 23, CMS Medicaid Director Dennis
Smith wrote to all state Medicaid Directors to “remind states
that there a number of options to prevent the inappropriate use of
such drugs and to inform states that we believe they should restrict
the coverage of such drugs in the case of individuals convicted of
a sex offense.” The letter instructs states immediately to “use
their drug use review programs and procedures under 1927(g) of the
Social Security Act and work with physicians and pharmacists to prevent
inappropriate
Medicaid payment …”
Return to top
FDA Reports Progress Against Counterfeit Drugs
In an annual update issued May 18 to its report “Combating
Counterfeit Drugs,” FDA indicated it has made substantial progress
in controlling market availability of counterfeit prescription drugs.
The report summarizes
action taken by the agency, particularly through its Office of Criminal
Investigations, which undertook 58 counterfeit drug investigations
in the year 2004, as compared with 30 in 2003.
Even as they pursued more cases, however, investigators determined
that most quantities of counterfeit drugs were smaller than had been
seen previously. The agency also has taken steps, the report says,
to improve coordination with other federal agencies, as well as state
and foreign law enforcement.
In addition, the update reports progress in the development and implementation
of Electronic Product Code (EPC) and Radio-Frequency Identification
(RFID) as tools to provide an accurate pedigree for drugs moving through
the commercial supply chain. The report states that three drug manufacturers
plan to incorporate RFID technology into at least one product by the
end of this year and a number of distributors have initiated pilot
programs for tagging products considered to be at risk of counterfeiting.
The update acknowledges that technical issues remain to be resolved
before RFID or related technology can be incorporated and used routinely,
including questions about the effects of RFID on drug products. In
particular, there are questions about the effects on biological/protein-based
products, which could be susceptible to change from this. FDA is working
with the Product Quality Research Institute (PQRI) on these questions
and with its own laboratory in the Center for Devices and Radiological
Health. Meanwhile, drug companies are using other kinds of tracking
and anti-counterfeit technologies such as holography and color shifting
ink.
FDA also points to a number of activities it has undertaken to inform
and educate the public about risks from counterfeit drugs, including
establishing the website www.fda.gov/counterfeit, public service announcements,
working with consumer groups to disseminate information in the form
of written materials, and encouraging physicians (and consumers) to
report potential counterfeit products via MedWatch.
Notwithstanding the reported progress and the ongoing commitment,
FDA says, “there remains a viable and concrete threat of counterfeit
drugs entering the U.S. drug distribution system.”
Return to top FDA
Publishes Draft Guidance on “Useful Consumer Information”
In the May 25 Federal Register, FDA published a draft
guidance, “Useful
Written Consumer Medication Information (CMI).” The guidance
is directed to individuals or organizations writing consumer information,
but who are not the manufacturer of a drug product. Since neither the
manufacturer nor the FDA would have any approval of, or veto over,
such information, the guidance recommends some steps these organizations
should take to make sure the information they provide to consumers
is accurate and useful.
FDA notes in the background to the guidance that the
law prevents the agency from regulating the content of consumer information,
unless
specific goals and timeframes could not be met by voluntary actions.
Among other steps to evaluate the extent consumers were receiving useful
information, the National Association of Boards of Pharmacy conducted
a study in 2001 for FDA’s Advisory Committee on Drug Safety and
Risk Management. The results indicated that while 89% of consumers
were receiving some written information with their prescriptions, on
average, the information was useful only about 50% of the time. The
Advisory Committee recommended FDA take a more active role in the matter.
The draft guidance is a response to that recommendation. The bottom-line
goal is for 95% of consumer to receive useful information with their
prescriptions by 2006.
Among the recommendations of the guidance is that information be scientifically
accurate, unbiased, understandable and legible, timely, useful, and
sufficiently specific and comprehensive. The guidance includes recommendations
for content and format; how to communicate contraindications, directions
for use, specific warnings, special storage conditions, etc. in the
most user-friendly way; how to present the name of the product most
comprehensively and usefully; and how to communicate instructions for
patient response to adverse reactions. The guidance recommends specifically
that information be provided in the order: personalized information
in a box, established and brand names, purpose/use of the medication,
warnings, instructions for use, side effects, and additional general
information.
Comments are due on the draft guidance in 60 days.
Return to top
National Science Advisory Board for Biosecurity Meeting
Scheduled The inaugural meeting of
the Department of Health and Human Services National Science Advisory
Board for Biosecurity (NSABB) will be
June 30-July 1, 2005. NSABB was established to provide advice, guidance
and leadership regarding federal oversight of usual-use research, defined
as biological research with legitimate scientific purposes that could
be misused to pose a biological threat to public health and/or national
security.
The agenda for the meeting includes a presentation
and discussions on criteria for defining dual-use research in the life
sciences and
the role of a code of conduct for the life sciences; discussion of
issues raised by dual-use research with respect to scientific communication,
genome synthesis, and international perspectives; and public comments.
Any member of the public interested in presenting oral comments at
the meeting may notify NSABB at least 10 days in advance of the meeting.
Interested individuals and representatives of an organization may submit
a letter of intent, a brief description of the organization represented
and a short description of the oral presentation. Written comments
will also be accepted until June 17, 2005.
Further information on the meeting is available at http://www.biosecurityboard.gov.
Return to top
OIE Shifts BSE Risk Recommendations, Rewrites Recommendations
The World Animal Health Organization (OIE) in Paris
this week completed its rewrite and approval of its chapter on BSE
risk and national categorization.
The focus of the meeting addressed three proposals: A recommendation
to add deboned skeletal meats and blood/blood products to the list
of “tradable" or exempt (non-risk) commodities; a shift
in the national categorization system from five categories to three
and a change in the surveillance criteria by which a nation would achieve
categorization.
Dr. Peter Fernandez, deputy administrator of USDA’s Animal & Plant
Health Inspection Service (APHIS) and president of the U.S. OIE
region, reported heavy Asian nation opposition to the changes, particularly
from Japan, Korea, Singapore and Taipei. Some South American nations
registered minor concerns.
The U.S. favors the OIE changes, a stance the U.S. has held and pushed
within OIE. When Asian delegates tried to place several stipulations
on meat trade, the U.S. asked: if OIE says meat is safe, what
will the world think about restrictions on its trade? Further, the
U.S. argued the recommendations were the result of consensus among
world scientific experts and questioned if the political delegates
to OIE to should challenge that consensus.
After two days of debate, the following changes were approved:
• Muscle meats are added to the list of tradable commodities
under the following conditions: shipments must be from animals under
30
months of age and must be accompanied by a veterinary certificate
showing the product did not come from an animal with BSE; there must
be ante and post-mortem inspection; no mechanically deboned product
is allowed and the animals can’t have been stunned using gas/air,
pithing or similar stunning methods. Blood and blood products were
accepted as non-risk, tradable commodities. Meat from animals over
30 months of age will trade under current standards. There will be
a push next year to remove the under-30-month provision.
• Under new categories of risk, the number of
categories drops from five to three -- "negligible risk", "controlled
risk" and "undetermined
risk." Countries now classified as free or provisionally free
nations (Argentina, Uruguay, Paraguay and Singapore) will resubmit
dossiers for a new classification. Other nations must now reapply for
a new category designation. USDA officials stressed the U.S. will now
consider its options in light of what other countries do and the dossiers
submitted. Any nation that has a submission in the OIE pipeline today
will be classified under the 2004 standards and would resubmit in one
year for a new category designation.
• The surveillance criteria were changed so
that to achieve 0 cases with 95% confidence of no BSE, a nation must
operate
under a 1/100,000
surveillance level; maintenance level would be 1/50,000 animals.
Return to top One More Baby Step By Japan on Beef Trade
Asking the fundamental question, “Is U.S. beef
as safe as Japanese beef?” the Japanese government this week
asked food regulators to study the feasibility of at least partially
lifting the current
ban on U.S. beef imports. The Food Safety Commission earlier this month
recommended the government waive cattle testing on animals less than
21 months of age.
Japan has 18 confirmed cases of BSE. The U.S. has detected one case
of BSE, in a cow imported from Canada.
Return to top
Conferees Named to Highway Reauthorization Bill
House and Senate leadership named conferees to begin
reconciling the respective chambers' version of federal highway program
reauthorization,
with the highest hurdle to overcome being the legislation’s price
tag. As evidence of that fact, the first meetings of the conferees
won’t take place until the first or second week in June – after
Republican leaders meet with the White House to get marching orders.
The White House has threatened to veto a highway bill costing more
than the $283 billion deemed adequate by the President; the Senate’s
bill costs out at nearly $295 billion.
Meanwhile, Congress approved its seventh extension
of the existing highway programs just before it left for its Memorial
Day recess.
The Senate bill contains language making permanent the hours of service
exemption for agriculture, valid within a 100-mile radius of the source
of commodities or distribution of farm supplies in each state. There
is also language allowing for the spending of federal dollars to control
invasive species and for revegetation efforts.
Return to top
Senate Committee Approves Comprehensive Energy Package; Showdown Set
on Senate Floor and With House Version
Having handled as many issues as it could without bogging down, the
Senate Energy & Natural Resources Committee this week completed
its markup of comprehensive energy legislation, opting to leave contentious
issues for the Senate floor debate and conference with the House.
Of significant importance to agriculture is committee
approval of an amendment to increase the amount of alternative fuels – ethanol
and biodiesel – mandated in the Renewable Fuels Standard (RFS)
for blending by diesel refiners. While the House bill carries a 6-billion-gallon
mandate, the Senate committee approved a mandate of 8 billion gallons
by 2012, doubling the amount of alternative fuel production in the
U.S.
Sen. Jim Inhofe (R-OK), chair of the Senate Environment & Public
Works Committee, urged the committee not to include the RFS amendment,
fearing it would jeopardize the bill on the floor. He cited a report
by the Energy Information Administration that estimates an 8-billion-gallon
RFS would increase the cost of gasoline by 2.4 cents per gallon. The
American Petroleum Institute, which represents refiners, said it was “disappointed” in
the committee’s action and predicted higher energy costs.
It’s expected Inhofe will prevail on the Senate floor, even
though groups such as the American Farm Bureau Federation and other
ag organizations support the higher RFS standard. If unsuccessful in
the Senate, the House has already signaled its unwillingness to go
along with the higher standard, with a final level at around 6 billion
gallons.
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Irish Authorities Seize U.S. Shipment of Corn Gluten Feed With Bt-10;
EE Continues Deadlock Over Biotech Corn Imports
In the up and down saga of Syngenta’s unapproved biotech corn
seed finding its way into corn and corn products, the Irish government
this week seized a U.S. shipment of corn gluten feed because it contained
the unapproved variety of Bt-10. The shipment was the first to test
positive since the European Union (EU) began requiring certification
and testing of U.S. corn and corn product imports in April.
Meanwhile, EU ministers failed for the 11th and 12th
time to reach accord on applications to import biotech corn into Europe.
The ministers
voted 8-9, with 8 abstentions, failing to approve an application
for corn-borer-resistant corn for feed use by Pioneer Hi-Bred and Dow
AgroSciences/Mycogen Seed. A second application for Monsanto’s
rootworm-resistant corn for import for use as an ingredient in processed
food was deadlocked on a 10-8 vote with 6 abstentions.
Return to top CAFTA Battle Heating Up
President Bush is targeting high-profile congressional
Democrats in his battle to win approval for CAFTA, but major deal cutting
will have
to happen before the treaty gets a floor vote in either chamber. In
addition, Secretary of State Condoleezza Rice and Secretary of Defense
Donald Rumsfeld have been meeting with targeted members of Congress
press the security issues included in the treaty.
Specific issues dividing the House and Senate on CAFTA
are sugar imports and labor protections. General ambivalence about
the treaty centers
on statistics showing the U.S. is already the biggest market for most
CAFTA-nation exports and market potential for U.S. products is relatively
low.
The White House push starts with Senate Finance Committee
Democrats – the
committee expects to hold a mock mark-up on the treaty June 13 – and
includes invitations to Sens. Max Baucus (D-MT), Jeff Bingaman (D-NM),
Blanche Lincoln (D-AR) and Ron Wyden (D-OR) to meet with Bush. The
strategy here is to get Democrat leaders to come to the pro-CAFTA camp,
thereby pulling moderate Democrats from the anti or undecided sides
of the issue. Finance Committee Chair Chuck Grassley (R- IA), along
with undecided committee members Sens. Ben Nelson (D-NE), Olympia Snowe
(R-ME) and Craig Thomas (R-WY), have also been invited to the meeting.
At the same time, other high-profile Democrats, including
several former members of Congress, are being enlisted to push the
CAFTA cause.
Former Rep. Cal Dooley (D-CA), now president of the Food Processors
Assn., and former House member and Secretary of Agriculture Dan Glickman,
now president of the Motion Picture Association of America, were at
a meeting this week with Hill types and Ambassador Rob Portman, U.S.
Special Trade Representative.
Return to top
Grain Standards Act Gets Review in House, Senate
A House Agriculture Committee subcommittee and the
full Senate Agriculture Committee this week held hearings as they begin
their reauthorization
of the U.S. Grain Standards Act. The Administration is asking the act
be reauthorized through 2015. The committees are reviewing several
sections of the Act set to expire, including authority to collect fees
to cover administrative and supervisory activities on grain inspections;
authority to collect fees to perform official inspections, official
weighing or supervision of weighing grain; the authority to receive
appropriations; the 30% cap on administrative and supervisory costs
and the authority for the USDA Grain Inspection Advisory Committee.
Return to top
EPA Wants Applications on Methyl Bromide Exemptions For Critical Use
The Environmental Protection Agency (EPA) is asking
for applications for a “critical use exemption” from the
phase-out of methyl bromide for 2007 and beyond. Users of methyl bromide
have the opportunity
to provide technical and economic information to support a critical
use claim. At the same time, EPA wants to hear about the technical
and economic feasibility of methyl bromide alternatives. Details of
the application process can be found in the May 23, 2005, Federal Register,
accessed at http://www.access.gpo.gov/.
Once the exemption applications are received, EPA will submit the
data for national U.S. nomination for review of the countries signed
on to the Montreal Protocol, which must approve critical use exemptions.
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.1118
Sen. Russ Feingold (D-WI) introduced a bill to reduce irrigation subsidies.
S.1126
A bill proposed by Sens. Charles Schumer (D-NY) and Hillary Clinton
(D-NY) would prohibit Federal funds from being expended for the payment
or reimbursement of a drug that is prescribed to a sex offender for
the treatment of sexual or erectile dysfunction.
S.1128
Sen. Ron Wyden (D-OR) offered a bill to provide for increased rebates
under the Medicaid program for prescription drugs that are directly
advertised to consumers, and to require other Federal programs purchasing
or reimbursing for such drugs to establish payment and reimbursement
mechanisms that reduce the costs of those drugs.
H.R.2541
Rep. Peter King (R-IA) introduced a bill to provide for the expansion,
intensification, and coordination of NIH activities regarding qualifying
adult stem cell research.
H.R.2562
A bill introduced by Rep. Sherrod Brown (D-OH) aims to preserve the
effectiveness of antibiotics used in the treatment of human and animal
diseases.
H.R.2565
Rep. Tom Davis (R-VA) proposed legislation to establish minimum drug
testing standards for major professional sports leagues.
H.R.2574
Rep. Roscoe Bartlett (R-MD) proposed a bill to provide for a NIH program
that would conduct and support research on animals to develop techniques
for the derivation of stem cells from embryos preserve the embryos.
H.R.2600
Legislation offered by Rep. Clay Shaw, Jr. (R-FL) amends the Federal
Food, Drug, and Cosmetic Act with respect to the sale or trade of
prescription drugs that were knowingly caused to be adulterated or
misbranded.
H.R.2626
Rep Chet Edwards (D-TX) introduced a bill to prohibit Medicare and
Medicaid coverage of sex-enhancing drugs for individuals convicted
of a sex offense.
H.R.2648
Rep. Vito Fossella (R-NY) proposed a bill to prohibit Medicaid from
providing coverage of erectile dysfunction drugs for individuals
registered as sex offenders.
H.R.2657
A bill offered by Rep. Brian Baird (D-WA) would provide medical malpractice
reform.
H.R.2685
Rep. John Larson (D-CT) introduced legislation to provide for prescription
drugs at reduced prices to Medicare beneficiaries.
Return to top
Inside
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