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In this Issue
Vote Expected on House Stem Cell Bill
Steroids in Sports in Headlines Again
House Subcommittee Discusses Generic Drug Utilization,
Strays Into Other Issues
E & C Subcommittee Investigates Products to Thwart
Drug Testing
Animal Rights Violence, Eco-terrorism
Taken on in Senate Hearing
FDA Announces Members of Drug Safety Oversight Board
USDA to Hold BSE Roundtable
R-CALF Pushing for Early Judgment on Border Complaint;
Alberta Premier Says U.S. Border Will Be Closed Two More Years
OIE Looks to Ease BSE Recommendations; Canada Seeking
Comment on New Import Standards
COOL Funding Cut By Approps Subpanel for FY2006
Senate Rejects Reduced Spending, Passes $300 Billion Highway Bill
Talent, Lincoln Introduce Biodiesel Tax Credit Extension
CAFTA Still on the Ropes as Bush Meets with Supporters
New Bills
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Vote Expected on House Stem Cell Bill
The House of Representatives has scheduled a vote for this Tuesday,
May 24 on “The Stem Cell Research Enhancement Act,” H.R.810.
Introduced by Reps. Mike Castle (R-DE) and Diana DeGette (D-CO), the
legislation would allow taxpayer dollars to be used for research on
donated embryos that are a few days old and stored in fertility-clinic
freezers.
With over 200 co-sponsors, House supporters of expanded stem cell
research say they are confident they have the 218 votes necessary to
pass legislation. However, on Friday White House spokesman Trent Duffy
said President Bush would veto any legislation that violates his principle
that "human life should not be created for the sole purpose of
destroying it." He added that the House legislation "is in
conflict with the president's principles.” The president has
yet to veto a bill passed by Congress.
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Steroids in Sports in Headlines Again
On May 18 and 19, the House Energy & Commerce
subcommittee on commerce, trade and consumer protection held a hearing
on the “Drug-Free
Sports Act,” H.R.1862. The heads of all the major sports organizations
and players’ representatives, as well as Frank Shorter, former
head of the U.S. Anti-Doping Agency, testified. Generally, the sports
organizations expressed concern about Congress getting involved, stating
they are taking sufficient steps to address the issue. However, they
also committed to follow any law Congress approves,
whatever the result.
H.R.1862 is designed on the principles of the U.S. Anti-Doping Agency.
It was generally viewed by the witnesses as providing for penalties
may perhaps appropriate for Olympic athletes, may not be appropriate
for those in professional sports. Subcommittee chair and author of
the legislation Rep. Cliff Stearns (R-FL) said he would take account
of the concerns expressed, review the bills provisions and try to make
appropriate modifications. He continued to say, however, federal legislation
is needed to standardize sports drug testing across the board and to
increase penalties to the point where they will deter unacceptable
steroid use behavior.
A statement issued by Energy & Commerce Committee Chair Joe Barton
(R-TX) expressed support for legislation and strong concern about steroid
use in professional sports. While acknowledging that things seem to
be improving as a result of teams, professional organizations, and
players taking action, he also said, “Nobody thinks athletes
should use illegal steroids. Nearly everybody thinks athletes can be
role models. So how in the world did we ever get in a position where
steroids are swallowed like M&Ms and adults winked at each other
when baseball players started growing arms as big as tree trunks?”
In related activity, the House Government Reform Committee continued
its oversight of steroid use in major sports by featuring the National
Basketball Association at a hearing May 19. Unlike the previously held
baseball hearing which featured multiple big-name players, this hearing
produced only one player, Juan Dixon of the Washington Wizards. Dixon
stated neither in his professional nor college basketball career had
he seen or had knowledge of steroid use by players.
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House Subcommittee Discusses Generic Drug Utilization,
Strays Into Other Issues
On May 18, the House Energy & Commerce subcommittee
on Health held a hearing on “Increasing Generic Drug Utilization:
Saving Money for Patients” and
took testimony from the Generic Pharmaceutical Assoc. (GPhA), AARP,
Kaiser Permanente, Caremark, and Dr. Scott Gottlieb of the American Enterprise
Institute. Although the hearing was billed as an opportunity to discuss mechanisms
that could increase prescribing and utilization of generic drugs, thus saving
money for the upcoming Medicare Part D benefit as well as other programs,
a number of unrelated issues were raised by witnesses.
In her testimony on behalf of GPhA, Kathleen Jaeger mentioned
a range of mechanisms to increase prescribing and utilization of generics,
including
encouraging states to redesign prescription pads so generics could be dispensed
unless doctors affirmatively indicate the brand must be dispensed; implementing
mandatory generic substitution programs; eliminating therapeutic substitution
carve-outs for certain categories of drugs, such as mental health, epilepsy,
and oncology medications, and implementing firm maximum allowable cost (MAC)
systems.
However, Jaeger went on to note Congress must address other
matters related to generic drugs including eliminating generic-harmful provisions
from trade agreements (such as IP protections in CAFTA), which she said could “upset
the U.S. balance of pharmaceutical innovation and access” and prevent
generic pharmaceuticals from being exported from the U.S.; deleting harmful
provisions such as “wild card exclusivity” from BioShield proposals;
and establishing or encouraging FDA to establish a pathway for generic biologics.
The written testimony of Dr. Jan Berger, on behalf of Caremark, also mentioned
the need to act on generic biologics.
Members’ statements and questions predictably strayed
from the topic of increasing generic drug utilization. For example, subcommittee
chair Rep. Nathan
Deal (R-GA) asked about review and approval times for generic drugs, and
whether Congress should consider user fees to improve this. Jaeger said the
playing
field for generic drug user fees has changed as a result of enactment of
Hatch-Waxman provisions in the Medicare Modernization Act, so the group could
reconsider this and would get back to the subcommittee.
Subcommittee raking member Rep. Sherrod Brown (D-OH), in
his opening statement, mentioned the “exploitation of consumers” through
patent extensions, abuse by brand companies of FDA’s citizen petition
process and authorized generics as anti-competitive. He also commented on
product exclusivity provisions
of BioShield, saying “even I didn’t expect the drug industry
to sink so low as to exploit terrorism in their quest for profits.” Deal
responded to Brown’s statement that he was sorry “PhRMA refused
to participate” in the hearing so it could defend itself,
noting PhRMA had not been invited and thus did not “refuse to participate.” In
questions to Jaeger, Brown referred to IP protection provisions of CAFTA
and asked whether the “brand industry will take those things and expand
to other countries or use CAFTA as leverage in the U.S.”
House Energy & Commerce Committee chair Rep. Joe Barton
(R-TX) said he shared Brown’s concern for extending patents for “tiny
changes,” and
about “gaming” to hold back market entry of generic drugs. He
asked whether the committee needs to act to make additional Hatch-Waxman
changes. Jaeger responded that MMA had made some important fixes, but that “we
are seeing new games” and should look at how to close new loopholes.
Rep. Henry Waxman (D-CA) focused his opening statement on
the need to lift the ban on CMS negotiating prescription drug prices, and
to “do all
we can to assure a process is put in place as soon as possible” for
generic biotechnology products. He subsequently asked Jaeger to discuss what
he called a bogus campaign by the brand industry to persuade people that
generic drugs may have only 80% of the active ingredient. In response, Jaeger
referred to specific “disinformation” regarding narrow-therapeutic-range
drugs, stating there is a “new wave” of such campaigns focusing
on mental health, epilepsy, and cancer medications. In responding to Waxman’s
question about how much would be saved through biotechnology generics, Jaeger
pointed to a $30 billion market for biological products, expected to increase
to $60 billion by 2010. She added that even with a modest market competition
of 20%, the savings would be enormous.
Rep Michael Burgess (R-TX) emphasized in his opening statement
the need for transparency in the marketplace so consumers would know price
differences
between brand and generic products. He emphasized, however, the decision
of what drug and which version to prescribe must remain in the hands of the
physician. He also raised the question of whether the cost of generic drugs
is too high, namely significantly higher than manufacturing costs. Finally,
as to “generic” biotechnology products, he noted these products
are quite different from drugs – the science is different and there is a
need to be very careful regarding legislating in that area.
In closing the hearing, Deal said he is interested in a
number of comments regarding generic biotechnology products. He said the
issue is
timely, though
complex and difficult, and he looks forward to working with Brown on a hearing
on the topic.
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E & C Subcommittee
Investigates Products to Thwart Drug Testing At
a May 17 hearing on “Subversion of Drug Testing Programs,” the
Energy & Commerce
subcommittee on oversight and investigations heard testimony from the
Government Accountability
Office
(GAO), the Substance Abuse and Mental Health Services Administration (SAMHSA),
representatives of the Attorney General and the Commonwealth’s Attorney
of Texas & Kentucky, and drug testing organizations and experts.
The hearing focused first on testimony from GAO regarding
its investigation which included having undercover agents contact various
sources of products
designed to thwart drug tests and purchasing such products. Among the findings
of the investigation was that companies promise their products can mask the
fact even true addicts, much less “social” drug users, have
used drugs. The products work and, unfortunately, there little ability or
inclination seems to exist on the part of states to make such products illegal.
Several witnesses called for federal legislation, pointing
to the difficulty of actually proving a company is responsible for illegal
activities
associated with its product. According to one witness, companies – which
principally sell the products over the Internet – express “shock” at
learning individuals on probation from prison are using the products
to “pass” their mandatory drug tests.
In addition, several members of the subcommittee expressed concern that
these kinds of products can be used not just by probationers, but also by
individuals such as bus and train drivers, pilots, and others for whom drug
testing is a component of public safety actions.
The committee earlier had issued subpoenas for the owners
of three companies who make these products, all of whom appeared at the hearing
and declined
to testify, citing their 5th Amendment rights. These were the presidents
of Puck Technology, Signal Hill, CA; Health Choice, Staten Island, NY; and
Spectrum Labs, Cincinnati, OH.
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Animal Rights Violence, Eco-terrorism
Taken on in Senate Hearing
On Wednesday, May 18 the Senate Committee on Environment & Public
Works held a hearing to highlight findings of the Committee’s investigation
into eco-terrorism and animal rights violence, specifically looking at
two named terrorists groups, the Earth Liberation Front (“ELF”)
and the Animal Liberation Front (“ALF”). Senators who were in
attendance at various times included Committee Chair Sen. James Inhofe and
Sens. John
Warner (R-VA),
David Vitter (R-LA), James Jeffords (I-VT) and Frank Lautenberg (D-NJ).
John Lewis, deputy assistant director for the FBI and Carson
Carroll, deputy assistant director for the Bureau of Alcohol, Tobacco, Firearms
and Explosives
(ATF) laid out strong cases as to why eco and animal rights terrorism is
the number one U.S. domestic terrorism threat and urged the committee to
work with
law enforcement
to strengthen federal sanctions. The “victims panel,” which included
Dr. David Skorton, president of the University of Iowa, Monty McIntyre, a
contractor from San Diego, CA who's development was burned down during construction,
and Bradley Campbell, commissioner of the New Jersey Department of Environmental
Protection, were also strong in their denunciation of the violence and
the cost in both physical and psychological terms from the attacks.
No animal rights
groups accepted an invitation to appear before the panel, but Inhofe said
on several occasions he was looking at holding another hearing and might
consider subpoenas for Ingrid Newkirk, cofounder and president of People
for the Ethical Treatment of Animals (PETA), and Steven Best, professor
at University of Texas, who has written and spoken about the justification
of
violence in pursuit of AR goals. Both Lautenberg and Jeffords defended activist groups.
Lautenberg said that the acts of a few individuals who are members of
these groups should
not taint an entire group. He said labeling these groups as terrorist is
excessive. Jeffords put in the record a statement from PETA on why it did
not appear, and asked that the record be kept open.
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FDA Announces Members of Drug Safety Oversight Board
On May 19, FDA announced the names of the members of its newly
constituted Drug Safety Oversight Board (DSB). The agency announced the establishment
of
DSB as part of its response to severe congressional criticism of its
drug safety activities. The board will review drug safety issues referred from
within the agency or that it identifies and to oversee the new FDA Drug Watch
web page.
The responsibilities and operations of the DSB are described
in an agency Manual of Policies and Procedures (see Inside Track, May 13).
The Board, expected
to provide oversight with respect to drug safety matters, may consult with
existing FDA advisory committees as well as outside experts and groups.
DSB
members include:
• Dr. Douglas Throckmorton, Deputy Director of
CDER, Chair (non-voting)
• Dr. John Jenkins, Director, Office of New Drugs
• Dr. Florence Houn, Director, Office of Drug Evaluation (ODE) III,
• Dr. Debra Birnkrant, Director, Division of Anti-Viral Drug
Products (alternates,
Drs. Sandra Kweder, Deputy Director, Office of New Drugs, and Robert Meyer,
Director, ODE II)
• Dr. Paul Seligman, Director, Office of Pharmacoepidemiology
& Statistical Science, Office of Drug Safety (ODS)
• Dr. Anne Trontell, Deputy Director, ODS
• Dr. Gerald Dal Pan, Director, Division of Surveillance, Research,
& Communication Support, ODS (alternates, Drs. Mark Avigan, Division
of Drug Risk Evaluation, and Carol Holquist, Division of Medication
Errors & Technical Support, both
in ODS)
• Dr. Solomon Iyasu, Acting Deputy Director, Division of Pediatric
Drug Development (alternate, Dr. Lewis Schrager, Team Leader,
Division of Counterterrorism)
• Dr. Susan Allen, Associate Director, Scientific & Medical
Affairs, CDER Office of Compliance (OC) (alternate, David Horowitz, OC
Director)
• Dr. Dena Hixon, Associate Director for Medical Affairs, Office
of Generic Drugs (OGD) (alternate, Dr. Lawrence Yu, OGD Director
for Science)
• Dr. Lawrence Lesko, Director, Office of Clinical Pharmacology
& Biopharmaceutics (OCPB) (alternate, Dr. Robert Powell,
Senior Pharmacist, OCPB)
• Dr. Robert O’Neill, Director, Office of Biostatistics (alternate,
Dr. Charles Anello, Deputy Director)
• Dr. Robert Temple, Director, Office of Medical Policy (non- voting)
• Dr. Karen Midthun, Deputy Director, CBER (alternate, Dr. Miles Braun, Director,
CBER Division of Epidemiology)
• Dr. Kimber Richter, Deputy Director for Medical Affairs, CDRH
OC (alternate,
Dr. Thomas Gross, Division of Postmarket Surveillance, CDRH)
• Dr. Charles B. Good, Chair, Medical Advisory Panel for Pharmacy
Benefits, VA (alternate, Dr. Peter Glassman, Staff Physician,
VA Hospital of Greater LA)
• Dr. Anthony Murgo, Acting Chief, Investigation Drug Branch,
NCI (alternate,
Dr. Margaret Mooney, Clinical Investigations Branch, NCI)
The board’s executive secretary is Dr. Susan Cummins,
CDER medical officer.
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USDA to Hold BSE RoundtableA national roundtable discussion on how BSE is affecting the U.S.
cattle industry will be held June 9 at the University of Minnesota,
Secretary of Agriculture Mike Johanns announced this week. While visiting
a cattle processing plant in Utah, Johanns said it’s time to
have a frank and open discussion. He wants to focus on the successes
of U.S. efforts at BSE mitigation, the USDA surveillance system, and
discussing how the American packing industry is being hurt by the on-going
Canadian border closure.
“Now is the time to put into perspective for producers, processors
and decision-makers the facts and the future implication of the course
we are following,” Johanns said.
The invitation-only roundtable discussion will review current science
behind beef safety; economic activity including market and job losses,
and shifting infrastructure. Anyone can attend to listen to the discussion.
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R-CALF Pushing for Early Judgment on Border Complaint;
Alberta Premier Says U.S. Border Will Be Closed Two More Years
In a move that has both opponents and legal experts scratching their
heads, the Rural Cattlemen’s Action Legal Fund (R-CALF) this
week formally asked a U.S. District Court judge to render a judgment
in the R-CALF action before the scheduled July 27 hearing. Some contend
this is an R-CALF ploy to extend and widen the ban on processed beef
and animal trade.
Meanwhile, Ralph Klein, premier of Alberta, said the “legal
wrangling” over opening the border will likely forestall live
animal and processed beef trade for another two years. “I believe
what I was told months ago,” Klein said, “that it would
probably be tied up in litigation for a couple of years.”
It’s unclear whether the judge who sided with R-CALF in slapping
a temporary ban on beef and animal trade will agree with the early
judgment request, a move rarely done. June 8 is the deadline for USDA
to respond to the latest R-CALF action, but has said it wants the court
to move in a deliberate manner.
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OIE Looks to Ease BSE Recommendations; Canada Seeking
Comment on New Import Standards
In reclassifying national status based on BSE incidents,
the World Organization for Animal Health (OIE) is looking to change
its standards,
shifting from how many BSE cases a country has had, to the completeness
of the country’s BSE mitigation/control program. It’s speculated
a “complete” program would require all specified risk
materials (SRM) be removed from animals where the beef will be exported,
and only boneless whole muscle cuts with no mechanical separation would
move in international trade. The classification system would be simplified
and a standardized global program of surveillance and testing would
be recommended.
Meanwhile, the government of Canada is asking for
comments on a new import policy that would bring Canada’s system
in line with the contemplated OIE changes, as well as with the North
American import
agreement among chief veterinarians announced at the end of March.
Observers said the import policy would be less restrictive than the
current 1997 policy, and would only apply to bovine animals – cattle
and bison – and their products.
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COOL Funding Cut By Approps Subpanel for FY2006
The House Appropriations Committee’s subcommittee on agriculture
this week again took action to delay mandatory country of origin labeling
(COOL) for meat by adopting language in the FY2006 spending bill that
stops USDA from spending any money to implement COOL. And while subcommittee
Chair Henry Bonilla (R-TX) said “this just buys us a little extra
time” – while listing the alleged horrors of mandatory
COOL – Sen. Byron Dorgan (D-ND) accused the House appropriators
of bending to the will of big meat packers.
“This is the second time that big packing companies have gotten
the majority party in the U.S. House to delay COOL for meat. It’s
time for Congress to stand up for American consumers and American ranchers,” Dorgan
said.
At the same time, Rep. Bob Goodlatte (R-VA) and several of his colleagues
introduced two weeks ago a bill to make COOL for meat voluntary. The
action does not apply to fresh and frozen fish, which began carrying
the mandatory labels in April.
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Senate Rejects Reduced Spending, Passes $300 Billion Highway Bill
Ignoring White House veto threats and internal efforts
to cut its price tag, the Senate this week approved an omnibus highway
spending
package estimated to cost $295 billion, $11 billion more than
the House bill and what the President recommended.
Senate Majority Leader Bill Frist (R-TN) stopped short of naming conferees
with the House, but staff has already begun preconference meetings
to reconcile the two packages. No word from Frist on when conferees
would be named, but the House said it would likely name its conferees
next week.
At the same time, leadership in both houses began drafting the seventh
extension bill to keep highway programs operating at current levels.
The current extension expires May 31.
Efforts to cut spending were to no avail following a vote by 76 Senators
to waive a budget point of order to bring the bill to the floor. Sen.
Jeff Sessions (R-AL) unsuccessfully offered an amendment to cut the
bill by $11.4 billion, mostly by taking $4 billion from clean air improvements
and $5 billion in transit funding.
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Talent, Lincoln Introduce Biodiesel Tax Credit Extension
A bill to extend through 2010 an excise and income tax for the production
of biodiesel was introduced this week by Sens. Jim Talent (R-MO) and
Blanche Lincoln (D-AR). A House companion bill is expected next week.
The tax break amounts to $1 per gallon for biodiesel made from soy
or first-use animal fats, and 50 cents per gallon for biodiesel made
from recycled products, including cooking oils. The break, authorized
last year in the FSC/ETI bill, would have expired at the end of 2006.
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CAFTA Still on the Ropes as Bush Meets with Supporters
Businesses supporting President Bush’s push to get CAFTA through
Congress met at the White House this week with the President and several
of his advisers – including U.S. Special Trade Representative
Bob Portman -- signaling the Administration intends to put more political
muscle behind the trade pact effort. The White House said it wants
to complete at least House action on CAFTA before the July 4 recess.
To hit the House deadline that chamber will
need to first dispense with a vote on U.S.-China trade before CAFTA.
The White House is concerned some members may tie their CAFTA votes
to action on China.
On the Senate side, the pact must be approved by the Senate Finance
Committee. With opposed or uncommitted Democrats, and some ambivalent
Republicans, Chair Chuck Grassley (R-IA) has had a tough time scheduling
committee review.
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New Bills
A number of new bills have been introduced. Click
here to send a request for a copy of the text or more information about
the bill.
S.1038
A bill offered by Sen. Richard Lugar (R-ID) would amend the Farm Security
and Rural Investment Act of 2002 “to enhance the ability to
produce fruits and vegetables on covered commodity base acres.”
S.1076
Sens. Blanche Lincoln (D-AR) and Jim Talent (R-MO) introduced a bill
to amend the Internal Revenue Code to extend the excise and income
tax credits for the production of biodiesel.
H.R.2399
Rep. Peter DeFazio (D-OR) introduced legislation to establish an Office
of Health Care Competition within HHS to administer the National
Practitioner Data Base and make more information on medical malpractice
insurance publicly available.
H.R.2400
DeFazio also offered a bill to establish an Emergency Malpractice Liability
Insurance Commission.
H.R.2485
A bill introduced by Rep. Dan Burton (R-IN) would authorize appropriations
to fully enforce and implement the Dietary Supplement Health and Education
Act of 1994.
H.R.2486
Burton also proposed a bill that would amend the Internal Revenue Code
to consider as medical expenses spending on dietary supplements and
medical foods.
H.R.2510
Rep. Frank Pallone (D-NJ) offered his own bill authorizing appropriations
to fully enforce and implement the Dietary Supplement Health and
Education Act of 1994.
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Inside
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All material © 2005 Policy Directions.
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