FDA Commissioner: The Saga Continues
The abrupt Sept. 23 resignation of Dr. Lester Crawford as FDA commissioner
has generated a week of media speculation on whether Crawford resigned or was
fired, allegedly for failure to include information in his financial disclosure
papers.
While Crawford, his wife and his brother-in-law have all talked with major
media outlets in the last week, Senate Help, Education, Labor & Pensions
Committee Chair Mike Enzi (R-WY) and ranking member Sen. Ted Kennedy (D-MA)
jointly called for the Department of Health & Human Services Inspector
General (IG) to investigate why Crawford resigned and if his resignation is
tied to his alleged ownership of stock in companies regulated by FDA.
In the Sept. 29 IG letter, Enzi and Kennedy said, “Specifically,
we would appreciate it if you would examine his financial reporting in accordance
with the various ethics laws … and the dates, … if any, in relation
to his financial holdings at those times that pose conflicts of interest with
regard to specific decisions he made in his official capacities at FDA.” In
part, the rationale for the investigation, according to the letter, is to assist
the committee in knowing, for future nominees, whether there are or have been
problems with disclosure of relevant information.
Enzi and Kennedy’s request was echoed by House Democrats
as Reps. Maurice Hinchey (D-NY), Marcy Kaptur (D-OH), Sam Farr (D-CA) and Raul
Grijalva (D-AZ),
asked the investigation be expanded to include other FDA officials, but did
not name specific individuals. Hinchey was the author of an amendment included
in the FDA appropriations legislation that would prevent the use of FDA funds
to grant waivers of conflict of interest for members of agency advisory committees.
The official White House version is Crawford resigned voluntarily, and his
public statement last Friday said he decided “at age 67, it is time to
step aside.” However, the New York Times’ coverage of the incident
included an unnamed White House source saying Crawford was asked to resign
over a financial disclosure problem. Crawford’s wife gave an interview
to the New York Times earlier this week in which she said her husband resigned
voluntarily and his action had nothing to do with any financial disclosure
issues. However, her interview was followed by an interview with her brother
who alleged the sale of a family-owned pharmaceutical wholesaler a few years
earlier was part of the problem.
Crawford called the Wall Street Journal and talked with Forbes
Magazine, restating his voluntary resignation and stating unequivocally he
did not own
stock in companies regulated by FDA. He explained he was tired of 20-hour days,
explaining the last few years of battles over over-the-counter contraception,
drug safety and other issues had tired him to the point he decided he could
not endure another two years of such battles. He also said he wanted to resign
so he did not have to go through the annual financial disclosure process, and
did not want to be a lame duck commissioner. He said it was time to start looking
for his next job.
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New
Acting FDA Commissioner Causing a StirFollowing the
sudden resignation of FDA Commissioner Dr. Lester Crawford, the Administration
immediately named Dr. Andrew von Eschenbach
acting
commissioner. Currently the head of the National Cancer Institute (NCI), von
Eschenbach released a statement indicating his commitment to FDA’s goals
and responsibilities and his high regard for FDA employees, including its leadership.
He also stated he would retain his position at NCI, to which he will return
when a permanent replacement for Crawford is named.
As soon as September 26, questions about this decision were
raised, including in a letter from Sen. Chuck Grassley (R-IA), chair of the
Senate
Finance Committee. Grassley has had a long-standing intense interest in FDA
matters and has held hearings and authored legislation focusing, in particular,
on product safety oversight by the agency. In writing to Andrew Card, White
House chief of staff, Grassley said “the nominee the President selects
to serve as Commissioner … demonstrate a clear understanding of the importance
of this position, and a willingness to dedicate 100 percent of his or her talents
and energy to the FDA.” The letter notes Grassley’s skepticism
that von Eschenbach can serve as both FDA acting commissioner and NCI director.
On September 27, Sen. Ted Kennedy (D-MA) wrote to HHS Secretary
Michael Leavitt about his “concern” over von Eschenbach's appointment.
The letter notes the importance of both FDA and NCI and points out that leading
either “is
an immense challenge that requires … total commitment.” Kennedy
also raises concern about “intrinsic conflicts of interest between the
role of NCI director, who manages a research program that includes drug development,
and the role of FDA commissioner, whose responsibility is to review the safety
and effectiveness of those drugs.”
Additional concerns about the appointment of von Eschenbach were raised in
a similar letter to Leavitt from Sen. Barbara Mikulski (D-MD), who said, “we
certainly can’t have someone who is straddling two jobs – no matter
how credentialed.”
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Grain Standards Act Goes to President Within
a week of each other, the House and Senate approved reauthorization of the
U.S. Grain Standards Act, sending the bill to the President.
The biggest sticking point in consideration of reauthorization was
a House proposal to allow companies to conduct their own
grain inspections at export ports. When Sen. Tom Harkin (D-IA) signaled
he could not support privatization of grain exports, and the Senate
went along with him, the House retreated from its position, passing
the identical bill approved in the Senate. Producer groups, including
the National Corn Growers Assn. and the National Farmers Union, opposed
privatization of grain export inspections, saying they feared foreign
governments would not accept privately inspected grains and oilseeds.
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FDA Proposed Feed Rule Delayed; Japanese Report Slams U.S. on Feed
Speculation FDA would publish this week its long-awaited proposed
rule modifying its BSE ruminant feeding regulations was shown to be
optimistic, as an 11th-hour snag apparently delayed the finalization
of the proposal. However, it is known the Canadian agriculture minister
was to be briefed late this week on developments in the U.S., as well
as how those developments might impact Canada finalizing its feed rule.
In a related development, a preliminary report done for the Japanese
Food Safety Commission says an analysis of U.S. data shows the risk
of BSE is five to six times greater in the U.S. than in Japan because
of so-called “loopholes” in American feeding restrictions.
Senate Agriculture Committee Chair Saxby Chambliss (R-GA) asked President
Bush this week to continue discussion of U.S. beef trade when the president
meets with Japanese Prime Minister Junichiro Koizumi during a Tokyo
layover on his way to an Asia-Pacific trade meeting in November. Chambliss
reminded Bush of the tenor in Congress following Senate approval of
language to stop a USDA rulemaking that would allow high-end Japanese
beef to come back to U.S. markets. If the Japanese don’t allow
U.S. beef into Japan, this would “sorely tempt economic trade
action against Japan. Japan is well beyond the time for assessing scientific
reasoning…and diplomatic efforts…,” Chambliss said.
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USDA Announces CRP Deadlines; Industry Voices Concerns
USDA announced this week it will begin accepting next spring applications
to re-enroll or extend contracts on 28 million acres of farm land now
in the Conservation Reserve Program, and an industry coalition expressed
concern over the potential negative impacts of the decision.
Agriculture Secretary Mike Johanns said most of the land in the program
is in 10-year contracts and over the next three years 28 million acres
under contract will expire. He also said USDA will use the Environmental
Benefits Index (EBI) to rank the land based upon the benefits it provides
through planting to grass, trees and ground covers, as well as its
impact on wildlife habitat and soil and water quality.
The Alliance for Agricultural Growth & Competitiveness (AAGC),
a coalition of national and state agriculture and agribusiness groups,
argued the current CRP program makes it too easy and attractive for
farmers to take otherwise arable, productive crop land and move it
into CRP in order to get payments. AAGC said in a press statement that
while there is no immediate concern over crop availability, “CRP
contract extensions will continue to be a contributing factor in placing
economic pressure on major sectors of U.S. agriculture heavily dependent
upon competitive supplies of grains and oilseeds, including livestock
and poultry producers.”
AAGC urged USDA to subject all expiring CRP acres to a competitive
bidding process that includes both environmental benefits evaluation
as well as rental rate review.
The coalition did not argue with a plan by USDA to
rank the extensions and re-enrollment. Under this plan the top 20%
will be eligible to
be enrolled for up to 10 years; the next 20% will be offered five-year
CRP extensions and the remainder will be allowed to sign up for two
to four-year extensions, in 20% increments. However, the group said
rental rates – not just the EBI -- should be a factor in
the re-enrollment.
Return to top Senate Hearings on FSA Closures Requested
Sen. Tim Johnson (D-SD) today called for hearings on USDA’s
plan to close up to one third of its more than 2,500 Farm Service Agency
(FSA) offices around the country. Johnson sent a formal request for
the hearings to Senate Agriculture Committee Chair Saxby Chambliss
(R-GA) and committee ranking member Sen. Tom Harkin (D-IA), saying, “I
find it troublesome that the USDA initiated a process of FSA service
center consolidation without public notice or comment.” South
Dakota would lose 14 of its 59 FSA offices under the proposal.
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House Ag Committee Members Question USDA’s Rosy Ag Income Report
While USDA continues to publish relatively rosy numbers on farm income,
a subcommittee of the House Agriculture Committee this week called
the portrayal into question. Rep. Jerry Moran (R-KS), chair of the
subcommittee on general farm commodities and risk management, held
a hearing to review the state of the farm economy and the impact of
federal policies on agriculture. The hearing also addressed that while
net cash farm income levels have hit record highs for the last two
years, recent USDA forecasts say income for 2005 will dip $10.7 billion,
mainly on higher costs for fertilizer, energy, manufactured input,
crop and livestock losses and interest rates. He also noted these numbers
do not reflect the impact of Hurricanes Katrina and Rita or the prolonged
midwestern drought.
USDA’s chief economist, Dr. Keith Collins, testified higher
energy costs are already cutting into farm income, and will “likely
continue to affect production input and marketing costs in 2006.” However,
Collins said that while energy-related costs have contributed to higher
production expenses, “net cash farm income has continued to rise
as cash receipts have stayed strong.”
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House Passes Controversial Endangered Species Act Rewrite
A rewrite of the federal Endangered Species Act (ESA) under which
landowners would regain some control over how their property is treated
while the federal government would take a smaller role in species protection,
was passed by the House this week. The ESA, enacted in 1973, protects
the survival of 1,268 species of plants and animals considered “endangered” or “threatened” by
extinction. Under the current ESA, the federal government can order
private land be set aside for habitat.
House Resources Committee Chair Richard Pombo (R-CA) called the current
act “a failure at recovering species,” saying his committee’s
bill – approved with lightning speed last week – would “put
the focus on recovery and protect private property owners.”
Denounced by environmentalists, the Pombo bill would eliminate “critical
habitats,” replacing them with “recovery plans” for
each species; it would specify landowners with development plans are
due answers from the Secretary of Interior within 180 days, with another
180-day extension possible, about whether the development would harm
a protected species, and if the government blocks the development,
the federal government would pay fair market value of the proposed
development, and provides that the Secretary of Interior make the decision
about the appropriate scientific data used in decisions.
Pombo defeated a substitute bill brought to the floor. The Senate
has not taken up the ESA, and acceptance of the House approach is far
from assured.
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Senate Aging Committee Looks at DTC Advertising
On September 29, the Senate Special Committee on Aging
held a hearing entitled “The Impact of Direct-to-Consumer Drug
Advertising on Seniors' Health & Health Care Costs.” Committee
ranking member Sen. Herb Kohl (D-WI) principally organized the hearing.
In his opening statement, chair Gordon Smith (R-OR)
noted the importance of achieving a consistent balance between promotion
and education,
so consumers get the most effective and useful information. He focused
on several policy questions, including the relationship between direct-to-consumer
(DTC) advertising and health care utilization and the appropriate communication
of risk information in advertising.
Sen. Ron Wyden (D-OR) said a need exists to educate consumers about
prescription drugs, but stated “people think prescription drug
advertising is completely out of hand.” He asked why, if the
purpose of advertising is to educate consumers, only blockbuster drugs
are advertised. Wyden also raised the question of what he referred
to as a “double subsidy” in the advertising tax benefit
coupled with payments from federal health programs. He referenced his
legislation, S. 1128, cosponsored by Sen. John Sununu (R-NH), which
would require increased rebates to Medicaid for advertised drugs and
changes in payment from other federal programs.
Testifying for FDA, Dr. Rachel
Behrman, deputy director of the Office of Medical Policy in the Center
for Drug Evaluation and Research, said while FDA’s research
indicates a benefit to consumers of DTC advertising, patients and physicians
believe ads often over-state benefits and under-state risks. She described
FDA’s regulatory authority with respect to drug advertising,
the history of changes in approach, the agency’s various outreach
and educational programs, and enforcement priorities.
Behrman referenced the pending FDA package insert
regulation, but she did not provide an expected date for issuing
the rule. The insert will
require a summary of the major label information at the beginning;
a draft guidance document on presenting risk information, in development;
and pending final guidances on help-seeking ads and the brief summary,
which will be completed after evaluation of findings from FDA’s
consumer research.
Responding to questions from Kohl, Behrman said recent increases in
warning letters reflect both a prioritization and focus on “egregious” violations
and the fact that until recently, there had been a “trend toward
violative” advertising. She also side-stepped a question about
whether FDA has sufficient resources in the face of substantial expenditure
on drug ads by simply saying FDA has 40 staff in the office of drug
advertising.
Asked by Wyden whether FDA has considered requiring ads to include
cost-effectiveness information, Behrman said FDA cannot tell companies
what to include in ads, but focuses on ensuring all information in
ads is truthful, not misleading, and supported by substantial evidence.
Wyden stated the “public wants to know about cost effectiveness” and
the government needs to look at this.
In response to a question from Sen. James Talent (R-MO),
Behrman said FDA is doing research on how individuals absorb information
and how,
in particular, they respond if risk information is “minimized.”
Other witnesses included:
Dr. Paul Antony, chief medical officer, Pharmaceutical
Research & Manufacturers of America (PhRMA), emphasized the value
of advertising
in educating consumers and highlighted PhRMA’s principles on
DTC advertising, recently approved by the board and vast majority of
PhRMA member companies.
Dr. Donna Sweet, chair of the board of regents, American
College of Physicians (ACP), reinforced ACP opposition to DTC advertising,
highlighted
the role pharmaceutical companies can play in supporting patient education
by non-profit organizations. In the absence of a ban on advertising,
she called for more stringent regulation to ensure consumers receive
more accurate information and doctors, rather than consumers, receive
information about new products;
Dr. Peter Lurie, deputy director, Public Citizen’s
Health Research Group, said DTC advertising does not advance public
health, is often
misleading and sometimes dangerous, leads to doctors being “coerced” into
unnecessary prescribing and FDA does not regulate advertising aggressively
enough.
Dr. Richard Kravitz, UC Davis Center for Health Services
Research, reported his recent research on the prescribing of antidepressants
illustrated the strong influence on physician prescribing of patient
requests for specific medications, leading to the conclusion that doctors
are “not always the stalwart intermediaries the pharmaceutical
industry claims and the law assumes.” He recommended a moratorium
on advertising of new drugs, more education about drugs through public-private
partnerships, and raising the bar “for DTC advertising in terms
of public health importance, safety, and effectiveness.”
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FDA Meeting to Address Advertising
An FDA public meeting on direct-to-consumer (DTC)
advertising, scheduled for November 1 - 2, will raise a number of questions,
including: “Does
current DTC promotion present the benefits and risks of using medical
products in an accurate, non-misleading, balanced, and understandable
way? Could changes in certain required prescription drug disclosures – the
package insert for print “promotional” labeling and the
brief summary for print advertisements – improve the usefulness
of this information for consumers? Could changes in the requirements
for disclosure of certain information in broadcast advertising improve
the usefulness of this information for consumers? As new communications
technologies emerge, they create opportunities for novel approaches
to DTC promotion. What issues should the agency consider with regard
to the effect of these technologies on DTC promotion? What action should
FDA take when companies disseminate violative promotional material
to consumers?”
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Qualified Health Claims Report Released
On September 28, FDA announced the release of a report
on the agency’s consumer research project, “Effects of
Strength of Science Disclaimers on the Communication Impacts of Health
Claims.” The project was conducted to try to determine how consumers
react to the recently announced FDA approach of allowing “qualified” health
claims on food labels, accompanied by a “grade” indicating
the strength of scientific underpinning for the claim. The research
involved asking consumers to react to mock-ups of food labels that
included several hypothetical claims, ranging from those backed up
by “significant scientific agreement” (i.e., traditional
health claims) to those supported by less scientific agreement.
FDA announced that its research suggests consumers
did not fully understand the meaning of qualified claims, but did appear
to understand and react to the “grade” regarding scientific
agreement. However, consumers believed a B grade to represent stronger
science than the agency had intended by this grade (there is no A grade,
just unqualified health claims). In addition, consumer judgments about
products bearing qualified claims were not what might have been expected,
with many consumers attributing more value to products with qualified
claims (i.e., less scientific certainty) than to those with unqualified
claims (i.e., significant scientific agreement).
To follow up on the study and its results, as well
as to discuss qualified health claims, FDA will hold a public meeting
on November 17 and accept written comments for 45 days thereafter.
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Moving Toward Health IT Interoperability
This week HHS announced members of the new American
Health Information Community. The Community has been established to
advise the Secretary
of HHS and recommend specific actions to achieve a common interoperability
framework for health information technology (IT) and serve as a forum
for participation from a broad range of stakeholders to provide input
on achieving interoperability of health IT. The first meeting of the
group has been scheduled for October 7 in Washington, DC. For more
information go to www.hhs.gov/healthit/ahic.html.
Also this week, the House Government Reform Committee held a hearing
on “The Last Frontier: Bringing the IT (information technology)
Revolution to Healthcare.” Two panels of government and industry
witnesses testified before the Committee, including Dr. David Brailer,
national health information technology coordinator, HHS and Dr. Robert
Kolodner, acting chief health informatics officer and acting deputy
CIO for health, VA. Brailer also said a standards harmonization group
will be announced soon and a consortium of state leaders will be established
to identify security and privacy advances and portability. He emphasized
the need for a single set of standards in implementation of a national
health IT network.
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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.1776
Sen. Mark Dayton (D-MN) introduced a bill to amend the Federal Crop
Insurance Act to establish permanent authority for the Secretary
of Agriculture to quickly provide disaster relief to agricultural
producers who incur crop losses as a result of damaging weather
in federally declared disaster areas.
S.1779
Legislation proposed by Sen. Daniel Akaka (D-HI) would amend the Humane
Methods of Livestock Slaughter Act to ensure the humane slaughter
of nonambulatory livestock.
H.R.3901
Rep. Robert Andrews (D-NJ) offered a bill to provide certain Medicare
beneficiaries living abroad a special Medicare part B enrollment
period during which the late enrollment penalty is waived and a special
Medigap open enrollment period during which no underwriting is permitted.
H.R.3918
Rep. John Peterson (R-PA) proposed a bill to terminate the effect of
all provisions of existing federal law prohibiting the spending of
appropriated funds to conduct natural gas leasing and preleasing
activities and to revoke Presidential withdrawals from disposition
of areas of the Outer Continental Shelf with respect to natural gas.
H.R.3931
Rep. Gary Ackerman (D-NY) offered legislation to amend the Humane Methods
of Livestock Slaughter Act to ensure the humane slaughter of nonambulatory
livestock.
H.R.3936
Rep. Bart Stupack (D-MI) proposed language on “price-gouging” of
gasoline and other fuels during energy emergencies.
H.R.3932
A bill offered by Rep. Mary Bono (R-CA) would prohibit human cloning.
H.R.3937
Rep. John Sweeney (R-NY) proposed legislation to include dehydroepiandrosterone
as an anabolic steroid.
H.R.3940
A bill introduced by Rep. Tom Price (R-GA) would extend implementation
of the Medicare prescription drug program.
H.R.3941
Price also offered a bill to establish a working group to identify
and advance the development and use of alternative sources for motor
vehicle fuels.
H.R.3942
Rep. James Sensenbrenner (R-WI) introduced a bill to establish a Federal
Office of Steroids Testing Enforcement & Prevention to establish
and enforce standards for the testing for the illegal use in professional
sports of performance enhancing substances and other controlled substances.
H.R.3950
A bill proposed by Rep. Rosa DeLauro (D-CT) would amend the Federal
Food, Drug, & Cosmetic Act with respect to drug advertising.
H.R.3956
Rep. John R. "Randy" Kuhl, Jr. (R-NY) introduced legislation
to provide for a drug discount program for individuals without prescription
drug coverage.
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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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