Hatch, Colleagues Re-Introduce Stem
Cell Bill
On April 21, Sens. Orrin Hatch (R-UT), Dianne Feinstein
(D-CA), Arlen Specter (R-PA), Ted Kennedy (D-MA), and Tom Harkin (D-IA)
introduced
S.876, the "Human Cloning Ban & Stem Cell Research Protection
Act of 2005." The bill is essentially identical to S.303 from
the 108th Congress.
The bill would make it illegal for anyone to “conduct or attempt” human
cloning, establishing criminal and civil penalties for these actions;
establish certain ethical requirements for stem cell (nuclear transplantation)
research, including requiring informed consent, prohibiting the sale
of cells, and prohibiting the maintenance of an embryo created through
somatic cell nuclear transfer beyond 14 days.
At a press conference of bill sponsors, Hatch emphasized
the importance of federal legislation to ensure this research — which
he stated is extremely important — is maintained under appropriate
controls, namely under ethical guidelines set by NIH. Saying his Utah
constituents
tell him the legislation is “the right thing” to
do, Hatch said “support is building across the country, and we
must act. If we do not seize this opportunities, other countries could
take the leading role in medicine’s next great advance. We will
lose the chance to set ethical guidelines, we will lose doctors to
overseas research institutions, and most importantly, we will lose
the chance to offer new hope to American and other patients ….”
Feinstein, calling stem cell research “the bright new frontier
of medicine,” noted not only other countries but also states
are taking matters into their own hands, appropriating funds for such
research and establishing their own rules. This, she said, is leading
to a dangerous patchwork of ethical requirements that could result
in activities that end up not being in patients’ best interests.
It is unclear whether this highly controversial topic will be dealt
with by Congress via enactment of this or similar legislation.
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DEA Cracks Down on Illicit Internet Pharmacy
In a nationally publicized raid, agents from several
law enforcement agencies, headed by the Drug Enforcement Administration
(DEA), arrested 20
individuals in the U.S. and overseas, bringing to a head
a lengthy investigation of illegal sales of controlled substances via
the Internet. According to the allegations, cyber sales of numerous
pharmaceutical controlled substances, including amphetamines, anabolic
steroids, and narcotics, were made without regard to the age of the
purchasers or a legitimate reason to receive these drugs, such as a
prescription.
The organization heading this Internet pharmacy operation
appeared to be based in India, with an Indian physician among the drug
supply
sources. The drugs apparently were sold through more than 200 websites
and often were re-packaged and sent without any identifying information
regarding the products’ appropriate or safe use, or even information
identifying the product. According to DEA, more than two million doses
of controlled substances have been sold each month in approximately
the last two years.
The DEA administrator called the Internet “an
open medicine cabinet” from
which “a vast array” of controlled substances are “doled
out.” John Walters, director of National Drug Control Policy,
called attention to the serious problem of prescription drug abuse,
noting young people and addicts are being targeted by Internet
purveyors attempting to “subvert our medical prescription system.” John
Taylor, head of the FDA Office of Compliance, reiterated the position
FDA has taken throughout years on congressional discussion of legalizing
prescription drug importation: “Consumers ordering prescription
drugs from a website they’re not familiar with put themselves
in a ‘buyer beware’ situation.”
Interestingly, at nearly the same moment this large-scale
effort was under way, the Senate Health, Education, Labor & Pensions
Committee was holding another hearing on legislation to legalize
prescription
drug importation (see article). The prognosis for this effort is not
clear, although it seems likely both the House and the Senate will
take up measures, in some form, before the end of the year. Legislation
also has been introduced in previous congresses to regulate sale of
pharmaceutical products online, but none of these bills has been successful.
It is unclear whether the face of the debate will change as a result
of strong law enforcement interest in this issue and evidence
prescription drug abuse among teens is growing at an alarming rate
and Internet traffic in controlled substances targets teens
and younger purchasers.
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Drug Imporation Takes Center Stage in Senate
HELP Hearing
Tuesday morning the Senate Health, Education, Labor & Pensions
(HELP) Committee held a hearing on “S.334: An Approach to Drug Importation.” Chair
Sen. Mike Enzi (R-WY) held the hearing at the request of bill sponsor
Sen. Byron Dorgan (D-ND). In the hearing, Enzi promised “we will do
something on drug reimportation." He later added drug companies
may have gotten the message it is a good idea to have lower drug
prices in the U.S.
David A. Kessler, former FDA commissioner, came out for
the first time in support of drug importation. Saying the “current
system is out of control,” he
asked Congress to take steps to protect consumers from the
current unregulated importation system. Kessler commended the Dorgan
bill for requiring
a carefully implemented phased approach with sufficient resources.
Bill co-sponsor Sen. Olympia Snowe (R-ME) said this legislation
addresses the two biggest concerns about importation: Safety and effectiveness.
She argued
this bill would be effective, based on recent comments on a similar
European Union (E.U.) system by Dr. Peter Rost, vice-president of marketing
from Pfizer. Countering this statement, Graham Satchwell, managing
director of Proco Solutions in the UK, emphatically noted Ross
has been proven wrong numerous times.
Also appearing before the committee, Sen. David Vitter (R-LA)
discussed his bill (S.109) as a slightly different approach then the
Dorgan/Snowe legislation,
but said he stands “shoulder to shoulder” with his colleague
and would support their bill if it came up for a vote. Vitter’s bill
places limitations on the types of drugs allowed, for example, none
that must be refrigerated. He also said it would be a mistake to limit
access to only one country, like Canada.
Sen. Judd Gregg (R-NH) went on the offense, setting off
a heated exchange with Dorgan and Snowe. Gregg said he has serious
reservations about their bill and is submitting 20 pages into the
record on his specific concerns. He said the way the bill is written,
it takes 100 years of law and
essentially replaces it with 40 pages that “you won’t explain … creating
a Russian roulette regime.”
Both Gregg and Sen. Patty Murray (D-WA) expressed concern over how this
legislation would create new burdens on FDA. Murray asked if a provision
existed in the bill to suspend importation if the new costs to FDA are unrealized.
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Internet Pharmacy Bill Introduced in House
“The Safe Online Drug Act of 2005” (SODA) was
introduced yesterday in the House by Reps. Greg Walden (R-OR) and Jim
Davis (D-FL). The legislations aims to create a uniform certification standard
for Internet pharmacies to ensure all U.S.-based Internet pharmacies
meet FDA safety standards and adhere to state regulations for operating
a
pharmacy. Current Internet pharmacy safety standards are voluntary.
In a statement, Davis said this bill “will take steps to crack
down on prescription drug abuse by prohibiting certified Internet pharmacies
from dispensing drugs without a valid prescription. This legislation
provides the best of both worlds by protecting consumers’ access
to the convenience of online pharmacies while removing the risk of
receiving illegal or counterfeit drugs.”
Additional restrictions in the bill would prohibit
Internet search engines from accepting advertisements from online pharmacies
that are
not properly certified. FDA certification for online pharmacies allows
only consumers with valid prescriptions to order medications and
pharmacies must
provide for authentication and security of prescription
orders. The legislation would also prevent credit card payments to
online pharmacies that do not meet certification standards, a provision
similar to the prohibition on credit card payments to illegal off-shore
gambling sites.
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"Assembly of Scientists" Opposing NIH
Ethics Rules
A group of NIH scientists who are fighting new ethics
rules that would end their financial ties to the drug industry have
hired Washington, D.C. law and lobbying firm Arent Fox.
According to reports, in an e-mail to NIH employees
on Tuesday, a group calling themselves the "Assembly of Scientists"
said it has"mounted
a legal and government relations campaign to challenge the new conflict-of-interest
rules.”
Contending the new restrictions impose unfair financial burdens on
them and will harm NIH's ability to recruit and retain top talent,
the scientists call for rescinding the stock-divestiture requirement
and allowing agency researchers to take consulting fees from the companies.
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House Passes Energy Bill with RFS; Senate Confrontation Looms
Taking seriously President Bush’s admonition
to “get off
the dime” and pass a comprehensive energy bill, and with the
input of five separate committees, the House this week approved a bill
including a Renewable Fuel Standard (RFS). The bill strongly resembles
last session’s conference report, including a number of controversial
provisions almost guaranteeing a confrontation with the Senate version
of omnibus energy legislation.
The RFS included in the "Energy Policy Act of 2005"
would require five billion gallons of ethanol and biodiesel to be in
the marketplace by
2010. The ethanol and motor fuels section also bans the use of the
gasoline additive MTBE by the end of 2014, but also provides for limited
liability protections to manufacturers. This issue also guarantees
a replay of last sessions’ confrontation in the Senate, especially
after the House GOP this week beat back Democratic amendments to remove
the
protection.
The National Corn Growers Assn. (NCGA) called the House action “a
major step forward.” Other high points for NCGA include clarification
of liquefied natural gas siting requirements by the federal government,
and creating and publishing a list of existing “boutique” fuels
by the EPA for use in setting caps.
The bill also permits “improved access to federal lands” for
energy exploration which translates, in part, into permission to
drill in the Arctic National Wildlife Reserve (ANWR), another hold-over
issue from last session’s bill that sets up a major conference
committee fight with the Senate.
The bill would require at least 80% of all dollars appropriated from
the Leaking Underground Storage Tank (LUST) trust fund to be sent to
the states to help run state underground tank programs, and after a
period of adjustment for the states to clear their backlogs, would
require onsite inspections of underground storage tanks every three
years. There are several other requirements on underground storage
tanks, including state reporting to EPA.
Return to top USDA Wants Comment on EQIP Priorities
USDA is asking for public comment on “national priorities and
emerging issues” for the Environmental Quality Incentives Program
(EQIP), and will hold a national listening session May 5 in Washington,
DC. EQIP was authorized in the 2002 Farm Bill, and provides financial
and technical assistance to farmers and ranchers “who face threats” to
soil, water and air, and related natural resources issues. The voluntary
program offers up to 75% cost share to help producers reduce soil erosion,
improve water use and protect grazing land by installing conservation
practices. Full information on the listening session can be found at
www.nrcs.usda.gov/programs/eqip.
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Portman Offers to Negotiate CAFTA Sugar Provision
Special U.S. Trade Representative-designate Rep. Bob
Portman (R-OH) this week offered during his Senate Finance Committee
confirmation
hearing to negotiate implementation of a controversial sugar provision
of the Central America Free Trade Agreement (CAFTA), according to reports.
Specifically the provision would allow the U.S. to compensate CAFTA
member countries, if the U.S. limits sugar imports, to prevent any
effect on the U.S. sugar program.
Portman, when asked by Sen. Larry Craig (R-ID) if
the sugar portions of CAFTA were negotiated properly, said the agreement
was crafted with
care. “It won’t affect the sugar program or open up the
Farm Bill,” he said. But CAFTA’s compensation language
is unique, and Portman offered to sit down with concerned Senators
and work out details “that make sense.” Sen. Charles Grassley (R-IA), chair of the finance panel, said he’d
call for a vote on the Portman nomination April 26. He said he wants
him confirmed before a May 2 mini-ministerial meeting on GATT to be
held in Paris so that Portman can attend that meeting in his new capacity.
Sen. Evan Bayh (D-IN) has a hold on the nomination, hoping to force
a vote on a measure to impose countervailing duties on subsidized imports
from non-market economies, including China.
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Conner Nomination on Hold Over Cuba
Sen. Larry Craig (R-ID) placed on a hold on the nomination of Chuck
Conner to be deputy secretary of agriculture over the Administration’s
continuing efforts to complicate – some argue derail – U.S.
ag trade with Cuba. Conner, whose confirmation hearing went smoothly,
is special assistant to the President for food, agriculture and trade
policy.
At issue is the Administration’s interpretation
of rules requiring payment by Cuban purchasers of U.S. ag goods to
pay in cash prior to
receipt. Secretary of Agriculture Mike Johanns was asked by reporters
this week if he had called Craig. Johanns said he hasn’t called
the Senator, but added he "can't wait until Chuck gets over at
USDA" because "his farm policy strengths are needed at USDA."
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Jeffords Announces He Will Retire
Sen. Jim Jeffords (I-VT), the Senate’s only independent and
the man whose party shift out of GOP ranks handed the Senate to the
Democrats for 19 months, announced this week he will not seek reelection
in 2006. He said he and his wife both have health concerns. His announcement
sets up a likely race for the Vermont seat between Rep. Bernie Sanders
(I-VT) and Gov. Jim Douglas, a Republican, insiders said. Neither man
has declared for the seat, but Sanders has made it known over time
he’d run if the opportunity presented itself.
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BSE UPDATE
Johanns Willing to Reconsider Downer Cattle Policy
Secretary of Agriculture Mike Johanns reportedly said this week
he is considering relaxing USDA’s strict policy of not allowing
non-ambulatory livestock – no matter the cause – from
entering the food chain. Johanns said a young animal with a broken
leg is not a BSE risk. Activist groups, including the Humane Society
of the U.S. and Farm Sanctuary, decried the potential action, with
both groups contending to relax the ban means increased inhumane
handling of livestock and a greater potential that diseased meat
will reach consumers.
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U.S. Technical Team in Japan, Korea
A team of USDA BSE technical experts traveled to Japan and Korea
this week, part of continuing U.S. efforts to reopen key Asian beef
markets. The delegation was led by Deputy Undersecretary Chuck Lambert,
with a goal of further explaining U.S. BSE mitigation programs and
urging both governments to adopt import regulations that track more
closely recommendations from the World Organization for Animal Health
(OIE). Following the U.S. visits, first to Korea, then Japan, both
nations are expected to send similar teams to the U.S. to review
beef production and processing systems.
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U.S. Groups File Amicus
Brief in Appeal of Canada Border Injunction; Canadian Conservative
Party MPs to Seek Intervenor Status
Seven major U.S. meat processing and retail groups this week filed
a friend of the court brief in support of USDA’s appeal of
a March 2 federal injunction against a rule that would have opened
the Canadian border to live cattle and expanded beef trade. The injunction
was granted at the request of R-CALF.
At the same time, Canadian Conservative Party members of Parliament
(MPs) said this week they will ask the U.S. federal judge to allow
them to participate in a July court hearing as intervenors. The ruling
Liberal Party in Canada sought and was denied friend of the court
status. If granted intervenor status, the MPs will participate in
the hearing, not just file written briefs. Liberal government leaders
stood behind their earlier strategy and speculated the intervenor
request will likely be unsuccessful.
The U.S. groups filing their brief are the American Meat Institute,
the North American Meat Processors Assn., Southwestern Meat Processors
Assn., Eastern Meat Packers Assn., American Association of Meat Processors,
National Restaurant Assn., and the United Food & Commercial Workers,
the union for slaughter/processing plant employees.
The brief argues the Montana District Court abused its discretion
by mandating continued closure of the border. U.S. and international
law require open borders unless there is a threat of disease introduction
and scientific evidence “makes clear” the border closure
is unnecessary.
The National Cattleman’s Beef Association
and the American Farm Bureau Federation - along with 19 state farm
bureaus - also filed amicus briefs with the U.S. Ninth
Circuit Court to demonstrate to the court USDA’s minimal risk
rule is based on science showing beef is safe from BSE. On April
21, Tyson Foods, the world’s largest meat packer, filed a friend
of court brief, calling the court decision bad law and bad for consumers.
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.813
Sen. Arlen Specter (R-PA) introduced a bill to authorize the Secretary
of Health & Human Services to negotiate for lower prices for Medicare
prescription drugs.
S.818
A bill offered by Sen. Chuck Grassley (R-IA) would make it unlawful
for a packer to own, feed, or control livestock intended for slaughter.
S.838
Sen. Russ Feingold (D-WI) introduced “Democracy for Dairy Producers
Act of 2005” that would allow modified bloc voting by cooperative
associations of milk producers in connection with a referendum on federal
milk marketing order reform.
S.869
Feingold also introduced “Federal Milk Marketing Reform Act of
2005” to prohibit the Secretary of Agriculture from basing minimum
prices for Class I milk on the distance or transportation costs from
any location that is not within a marketing area.
H.R.1802
Rep. Dennis Rehberg (R-MT) offered legislation to on the marketing
of imported live bovine animals.
H.R.1808
Rep. Greg Walden (R-OR) introduced a bill to regulate Internet pharmacies.
Return to top
Inside
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