Energy & Commerce Plans Hearing
on Generic Drug Use
On May 18, the House Energy & Commerce health
subcommittee plans to hold a hearing on increasing the utilization
of generic drugs.
The
subcommittee plans to invite representatives of payers, the generic
drug industry, and others, with a view toward understanding how to
increase utilization of generic drugs.
The hearing is driven in part by the fact that the Energy & Commerce
Committee (like the Ways & Means Committee, in the case of Medicare)
will be looking for ways to achieve substantial savings in the Medicare
and Medicaid programs, under the Budget Resolution. The subcommittee
hopes to identify how at least some of these savings could come from
increased use of generic drugs by beneficiaries of these programs,
and by implementation of techniques to assure increased use by various
payers.
Although the hearing is not intended to address other
generic drug issues, there is no question other matters will be raised,
such
as “authorized generics,” generic or follow-on biological
products, so-called “wild card exclusivity,” (such as proposed
in a Senate-introduced Bioshield II bill as an incentive for companies
to develop bioterrorism agents), and other issues that define the ongoing
battles of innovator vs. generic drugs.
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Senate Bioterrorism Subcommittee Holds First “Threats” Hearing
On May 11, the Senate Health, Education, Labor & Pensions subcommittee
on Bioterrorism and Public Health Preparedness held a hearing on “21st
Century Biological Threats,” launching the subcommittee’s
study on the need for legislation and administrative actions to ensure
optimal preparedness for bioterrorism attacks. According to subcommittee
chair Sen. Richard Burr (R-NC), “In the days since September
11, we’ve made great progress in better preparing ourselves for
a bioterror attack. Clearly, however, there is more to do.”
Witnesses included Dr. John Deutch, Professor at the Massachusetts
Institute of Technology and CIA Director and Deputy Secretary of Defense;
Dr. Harvey Fineberg, President of the Institute of Medicine of the
National Academies of Science; Dr. Craig Venter, Director of the Venter
Institute; Dr. Guenael Rodier, Director of the Department of Communicable
Disease Surveillance and Response of the World Health Organization;
and Dr. Shelley Hearne, Executive Director of Trust for America’s
Health.
Deutch urged improved intelligence about bioterrorism
threats, training and resources for first responders, and emergency
procedures
and policies; enhanced research and development of new ways to detect
and treat diseases from biological agents; and re-instituting across-the-board
immunization against smallpox. While he acknowledged the smallpox threat
may be small and there is a need to address liability protections for
manufacturers of smallpox vaccine and compensation for those who may
be injured by a vaccine, he stated such vaccination is needed.
Rodier focused on the global nature of the threat from known, emerging
and unknown microbial agents and of the growing problem of antimicrobial
resistance. He urged all countries strengthen early warning systems
and response capabilities so outbreaks of disease can be controlled
locally and do not become epidemic.
Also discussing microbial threats, Fineberg noted
variations in the capacity and capability of public health systems
to respond
to and manage problems continues and is a serious hurdle. He also mentioned
the growth of antimicrobial resistance, a relative dearth of new antimicrobial
agents available or in development, and the dangerous decline of vaccine
manufacturers.
Venter focused on the promise of new biotechnology approaches and
techniques, including genomics, in identifying and controlling threats.
He urged continued funding for basic research, especially in areas
such as genomics, as well as increased support for developing new methods
for better and faster detection of emerging infectious agents. Finally,
he supported the establishment of additional incentives for pharmaceutical
and biotechnology companies to develop products such as new vaccines
and antimicrobials, as well as specific anti-bioterrorism agents. He
specifically mentioned directed government funding, similar to the
Defense Advanced Research Projects Agency of the Department of Defense.
Burr indicated his intention to hold several hearings regarding these
issues, and consider Bioshield II legislation to build on what already
is being accomplished under Bioshield I.
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Crawford FDA Nomination Further Muddled
The nomination of Dr. Lester M. Crawford to be Commissioner of the
Food & Drug Administration (FDA), already put on temporary hold
because of anonymous allegations, now confronts additional issues.
Still concerned about FDA’s action (or lack
thereof) to convert the Plan B contraceptive product to over-the-counter
status, Sens.
Hillary Clinton (D-NY) and Patty Murray (D-WA) now have an additional
concern. According to press reports, Dr. David Hager, a member of the
FDA reproductive drugs advisory committee, has revealed he sent
a memo to the agency after a majority of the committee approved changing
to OTC status and he voted against it. Hager, who is also a minister,
reportedly gave a sermon in which he described his memo and stated
his view that the Plan B OTC switch would have been evil. He also stated
that his memo, laying out additional scientific concerns about the
OTC switch, was influential in persuading FDA to take a course of action
different from that recommended by a majority on the committee. After
learning of this memo, Clinton and Murray asked HHS Secretary Mike
Leavitt to look into the matter. They indicated that until this
is resolved, they would oppose Senate approval of Crawford’s
nomination.
If that weren’t enough, Sen. Tom Coburn (R-OK)
is now saying he intends to hold up the nomination for an unrelated
reason.
According to Coburn, FDA should have implemented a congressional directive,
included in an appropriations bill in 2000, to modify the labeling
of condoms to make clear they do not prevent all sexually transmitted
diseases. The time in which this should have been done, said Coburn,
was on Crawford’s watch. In response, FDA said a proposal was
sent to the Office of Management & Budget (OMB) earlier this year and
is pending.
The 2000 appropriations bill provision in question requires the Secretary
of HHS to “reexamine existing condom labels … to determine
whether the labels are medically accurate regarding the overall effectiveness
or lack of effectiveness … in preventing sexually transmitted
diseases, including HPV [human papilloma virus].” This provision
stops short of what was included in legislation passed by the House
that same year, but not enacted, to render a condom misbranded “unless
its label and labeling bear information providing that condoms do not
effectively prevent the transmission of the human papilloma virus and
that such virus can cause cervical cancer.”
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FDA Drug Safety Activities Step Up
On May 4, FDA issued a chapter of the Center for Drug
Evaluation & Research (CDER) Manual of Policies and Procedures (MAPP)
outlining
the organizational structure and responsibilities of the new Drug Safety
Oversight Board, an entity announced several months ago by Acting FDA
Commissioner Lester Crawford. According to the MAPP, this board will “provide
independent oversight and advice to the Center Director” and “manage
the dissemination of certain safety information.” Anyone on the
Board who was involved in the review of an application, or in making
a regulatory decision, will be recused from the Board’s voting
related to that product or application.
Board membership will include the Deputy Director
of CDER as the non-voting chair; three individuals and two alternatives
from each of the Offices
of Drug Safety & New Drugs; one individual and one alternative from
each of the Offices of Counter Terrorism & Pediatric Drug Development,
Compliance, Pharmaceutical Science, Clinical Pharmacology & Biopharmaceutics,
and Biostatistics; and one individual and one alternate from each of
CBER, CDRH, a non-FDA HHS agency such as NIH, and a non-HHS health
organization such as the VA or DoD. The director of the CDER Office
of Medical Policy also will be a non-voting member.
The MAPP lays out how the Board will operate, including: the Board
can establish subcommittees and working groups, hire consultants, etc.;
that any CDER organization may refer an issue to the Board; that Board
decisions will be recommendations to the CDER Director; and that all
non-FDA members will be screened for conflicts of interest. The MAPP
makes clear that final authority for regulatory decisions rests with
the CDER Director.
In further action, in the Federal Register of May 10, FDA published
a Draft Guidance on its newly announced “Drug Watch” web
page, on which the agency will post emerging drug safety information.
The document acknowledges all drugs have risks and that there
generally is a period of uncertainty after a safety report is received
during which the agency and the product sponsor work to verify information
and identify next steps. However, the document also emphasizes the
importance of advising consumers and physicians as soon as possible.
The Draft Guidance “FDA’s ‘Drug Watch’ for
Emerging Drug Safety Information” states the Drug Watch page
might post factual information about newly observed serious adverse
events, information about serious emerging risks FDA believes could
be associated with a drug, or information about the implementation
of a new risk minimization procedure.
The Draft says most information to be included
in this page currently is available publicly through Freedom of Information
Act requests. There will be a disclaimer, according to the Draft, on
any information the agency is still evaluating, stating that the information
is based on a preliminary analysis and is not conclusive. Among the
factors the agency will consider in deciding what information to post
will be whether the new safety information could have a significant
effect on prescribing or use decisions, whether providing the information
will allow steps to be taken to prevent harm, and whether off-label
use “appears to pose a significant risk to patients.” It
will be one of the new Drug Safety Oversight Board’s responsibilities
to manage this web page, determining what information to post and when
drugs will be removed from the page.
Drug sponsors would be notified before the first posting of their
drug on the page. The Guidance states that information on the Drug
Watch page, or the fact that a drug appears there, may not be used
in promoting other products.
Comments on the Draft Guidance are due August 10.
A meeting on May 18 and May 19 of the FDA Drug Safety
& Risk Management Advisory Committee will add additional fuel to the
drug safety discussions.
The committee is meeting for two days to “explore issues related
to FDA’s risk assessment program for marketed drugs.” The
committee will hear presentations from FDA and the public, and is asked
to discuss and possibly make recommendations regarding the advantages
and disadvantages of the current system or alternate approaches to
detecting risk signals.
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Stem Cells to be on House Floor A House floor vote on “The Stem Cell Research Enhancement Act
of 2005,” H.R. 810, a bi-partisan bill sponsored by Reps. Mike
Castle (R-DE) and Diana DeGette (D-CO) is expected as early as next
week. House Republican leadership had previously promised a clean vote
on legislation to broaden funding for stem cell research. The bill
specifies federally 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.
New poll data was released by the Republican Mainstreet
Partnership on Republican attitudes towards stem cell research, both
nationally
and in key Republican-held congressional districts. They have also
launched a new advertising campaign to encourage Republicans Representatives
to support the Castle/DeGette Stem Cell Research Enhancement Act.
The poll findings include:
•
Republicans nationally favor embryonic stem cell research by a 55-38%
margin.
•
79% of Republicans believe finding a cure for disease is a moral
obligation
•
69% believe stem cell research can generate significant advances,
though they split three ways between whether embryonic or adult or
cord blood sources are most promising, and a similar number "don't
know."
•
Asked whether this is a scientific issue or a right-to-life issue,
Republicans said scientific issue by 54-40% margin.
•
In key Republican Congressional districts, all voters favored embryonic
stem cell research by a 66-27% margin, and Republicans in those districts
supported the research 53-37%.
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Counterfeit Drug Bill Offered in House
This week Rep. Steve Israel (D-NY) introduced “Tim Fagan’s
Law” or the “Counterfeit Drug Enforcement Act of 2005” (H.R.2345).
This legislation would make it a crime for a person to adulterate or
misbrand a drug for sale or trade; or knowingly buy an adulterated
or misbranded drug. Punishment includes fines and/or imprisonment for
up to life.
Manufacturers hold primary responsibility in this bill which requires
manufacturers that receive or are aware of adulteration or misbranding
to report the information to the Secretary within 48 hours. The Secretary
also has the power to consider drugs misbranded if the manufacturer
fails to use technology deemed technically feasible by the Secretary.
Proof of a chain of custody must be maintained from the drug manufacturer
throughout the wholesale distribution to a pharmacist. However, once “track
and trace” or other feasible technology is available this requirement
will not apply. Excluded from this requirement are intracompany sales
or sales within group purchasing organizations. Further requirements
on manufacturers include maintaining at corporate offices a current
list of the authorized distributors of a drug.
Authorization for this bill includes $60 million per year for FDA
to conduct inspections, examinations and investigations on suspected
counterfeit drugs. In addition, $5 million per year is authorized for
the Secretary to educate the public and health care professionals on
counterfeit drugs, including how to identify counterfeits drugs.
The Secretary is also given authority to immediately order a cease
in distribution of a drug and notify health professionals of the order
if he is reasonably sure a drug could cause serious, adverse health
problems or death. Finally, the bill gives the Secretary and Attorney
General the authority to issue subpoenas for the investigation of counterfeit
drugs.
The bill is named after a 16-year old who in 2002 underwent a liver
transplant. Fagan’s parents purchased prescription drugs at a
major pharmacy; however, the drugs they purchased turned out to be
counterfeit.
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Johanns Approves Funding for Soybean Rust Surveillance
Network
Over $1 million in contingency money will be spent by USDA to monitor,
report and manage soybean rust during the coming growing season, Secretary
of Agriculture Mike Johanns said this week. Johanns said $1.2 million
will help enhance the federal, state and industry-coordinated effort
so that producers get good information on where soybean rust exists
and how to best protect against it.
USDA’s Animal & Plant Health Inspection Service (APHIS)
will apply the funding to soybean rust surveillance and monitoring;
predictive modeling; web-based information dissemination; finalizing
fungicide criteria and communications/outreach. About $800,000 will
be spent on setting up sentinel plots in 35 states and Puerto Rico,
$120,000 will be spent on mobile survey units, and $210,000 will be
spent on updating and maintaining the new USDA soybean rust website
at www.usda.gov/soybeanrust.
The fungus was first found in Louisiana last year. It is now in eight
other states: Alabama, Arkansas, Florida, Georgia, Mississippi, Missouri,
South Carolina and Tennessee.
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to top
Goodlatte Meets With Ag Groups to Talk Budget, Reconciliation
The good news is ag will only take a $173 million spending hit in
FY2006 ($3 billion through 2010), but the bad news is now those cuts
have to be reconciled with existing spending authority. Ag groups are
worried about where those cuts will fall. To find out how worried these
groups are, House Agriculture Committee Chair Bob Goodlatte (R-VA)
called a meeting of farm production organizations this week, saying, “Let
me emphasize it is my intention to guide the committee through reconciliation
in a careful and deliberate manner.” He also said he would be
calling regular meetings of affected groups to get their input on the
budget cutting process.
Under the budget reconciliation system, once the total
amount of budget cutting is determined, the committee’s that
authorize the federal programs must go back to the drawing board and
submit a
plan to the
House Budget Committee on how and where those cuts will be made. These
plans are due by Sept. 16, 2005.
Return to top CAFTA Will Be Rejected, Says ND Senator;
Heads of CAFTA Nations Join Bush in Pushing for Trade Pact
The Central America-Dominican Republic Free Trade Agreement (CAFTA)
will not be approved because Congress is “drawing the line” on
failed U.S. trade initiatives that have contributed to this nation’s
overall trade deficit, said a leading Senate critic this week.
Sen. Byron Dorgan (D-ND), who with Sen. Lindsey Graham
(R-SC) is leading the Senate charge against CAFTA, issued his prediction
May
12, the same day the six presidents of CAFTA nations were in Washington,
DC, to rally support for the agreement. Dorgan called the appearance
of the six chief executives on Capitol Hill “unprecedented and
desperate” lobbying of Congress by foreign heads of state.
President Bush said passage of CAFTA is crucial to America’s
security and commitment to democratic change in Central America and
the Caribbean.
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Federal Court Upholds CAFO Ruling
The federal court this week refused to reconsider its February 28
ruling on EPA’s confined animal feeding operation (CAFO) rule,
restating that animal producers who do not actually discharge into
U.S. waters do not have to apply for discharge permits under the Clean
Water Act. The U.S. Court of Appeals for the 2nd Circuit rejected a
rehearing sought by environmental groups that held all producers, whether
they discharge into waters or not, should be required to have permits.
The court agreed with the environmental groups that when a permit is
required, the nutrient management plan must be included in the permit
and open for public review.
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Senate to Take Up Highway Bill, Defying
Bush Veto Threat Over Cost
The Senate began formal consideration of the omnibus
highway program reauthorization bill late this week, a bill that faces
a possible White
House veto over its cost. President Bush has said the bill can cost
no more that $283.9 billion; the Senate package is estimated to cost
nearly $300 billion over six years. The House bill, passed last month,
meets the White House cost target but faces Administration displeasure
because it carries a provision allowing it to be reopened to increase
spending after three years.
Sen. James Inhofe (R-OK), chair of the Senate Environment & Public
Works Committee, will offer next week a substitute bill that addresses
concerns by Senators from states that pay more in federal gasoline
taxes than they receive in federal highway aid. His bill would authorize
about $251 billion in direct transportation payments and shift
dollars to highways and transit funding. Together with FY2006 spending
expectations, the bill’s cost is $295.6 billion.
The Senate is expected to vote on the full package May 17. As of May
13, more than 30 amendments had been submitted for consideration when
the full Senate meets.
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BSE UPDATE
New Indications Japan
Closer to Opening Beef Trade;
Japan Confirms 18th Case of BSE
Japanese lawmakers from that nation’s ruling party this week
endorsed a plan to lift Japan’s ban on imports of U.S. beef.
The action, a meeting of major party leaders and ministry officials,
came about after Japan’s Food Safety Commission recommended
the government waive animal testing for domestic cattle less than
21 months old. This cleared the way for the same standard to be used
with imported animals and products.
Meanwhile, all 47 Japanese states – prefectures – will
continue to blanket test cattle for BSE. A Holstein cow, said to
be over 5 ½ years old, is the latest confirmed
case of BSE in Japan, the 18th case so far. The cow was found in
the Hokkaido
prefecture.
The only hitch in this chain of seeming positive
developments is the Japanese government refuses to set a date for
resumption
of trade.
The government wants the Commission to deem U.S. beef as safe as
Japanese beef and to take public comment. The public comment period
began May 13 and continues until May 20.
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Biotech Cow to be Used in BSE Immunity Testing in Japan
A genetically modified cow developed by a South
Korean team of researchers will be used in Japan to see if the animal
is immune to BSE. The
animal is being used in testing at the University of Tsukuba Laboratory
Animal Resource Center. In December 2003, Dr. Hwang Woo-seok, a
professor at Seoul National University, announced he and his team
had produced four genetically modified calves they claim are BSE
resistant.
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Oman Opens Market to U.S. Beef
The government of Oman lifted its ban on U.S. beef
and beef products this week. This adds $61,000 to the U.S. beef trade
plus
column.
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USDA BSE Cattle Testing Nears 350,000
By the time you read this, USDA will have tested over 350,000 beef
animals for BSE. As of May 12, 347,491 animals had tested negative
for BSE, with testing averaging over 8,000 animals a week.
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USDA Unveils Multi-Year Animal ID Plan
USDA is seeking comment on its intention to issue
a multi-year animal identification plan. Secretary of Agriculture
Mike
Johanns
this week
released a “thinking paper” and a timeline on animal
ID, and asked industry leaders to provide feedback. The paper says
USDA wishes to have in place stakeholder premises and animal ID procedures
by January 2008, and defined animal-movement recording is to be
in place by January 2009. The full documents can be found at www.usda.gov/nais.
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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.
H.R.2234
Rep. Tim Murphy (R-PA) introduced a bill to authorize HHS to make health
information technology grants.
H.R.2299
Legislation offered by Rep. Frank Pallone (D-NJ) would require FDA
to establish therapeutic equivalence requirements for generic drugs.
H.R.2308
A bill introduced by Rep. Dave Weldon (R-DE) would provide for clinical
research support grants, clinical research infrastructure grants
and a demonstration program on partnerships in clinical research.
H.R.2345
Rep. Steve Israel (D-NY) introduced a bill to increase criminal penalties
for the sale or trade of prescription drugs knowingly caused to be
adulterated or misbranded, to modify requirements for maintaining
records of the chain-of-custody of prescription drugs and to establish
recall authority
H.R.2352
Rep. Ron Paul (R-TX) offered legislation that would require health
claims for foods and dietary supplements include accurate statements
of the curative, mitigation, treatment and prevention effects of
nutrients on disease or health-related conditions.
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Inside
Track is produced as a service to clients of Policy Directions,
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All material © 2005 Policy Directions.
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