Crawford Resigns as FDA Commissioner
Dr. Lester Crawford, Commissioner of the Food & Drug Administration (FDA),
resigned today in the following email sent to all FDA staff.
To: FDA All-Hands
From: Commissioner of Food and Drugs
Date: September 23, 2005
Re: Resignation
I have today resigned my position as Commissioner of the Food and Drug Administration
(FDA). After three and a half years as Deputy Commissioner, Acting Commissioner
and, finally, as Commissioner, it is time at the age of 67, to step aside.
I am doing so with deep gratitude to the President and both Secretaries of
Health and Human Services for whom I have been privileged to serve.
I also must thank the extraordinary people of FDA for the honor of having
served with them a fourth time over a 30 year period. They have made public
service a joy and a pleasure as we worked together to accomplish great things
for public health. Certainly, the Critical Path Initiative, the Drug Safety
Program, the three user fee acts passed since 2002, and the various good manufacturing
practice reforms will continue to make a difference in the lives of all Americans.
Most importantly, I have to thank my family for their constant support. I
also appreciate the encouragement of so many Americans from all walks of life
throughout my FDA career.
/s/
Lester M. Crawford, DVM, PhD
Return to top Senate Ag Appropriations Wrap-UpThe Senate this week completed work on the FY2006 appropriations
bill, approving nearly $101 billion in spending for USDA and the Food & Drug
Administration. The bill was completed faster than expected when Sen. Robert
Bennett (R-UT),
chair of the Senate ag appropriations subcommittee convinced several senators
to withhold controversial amendments that might slow down that portion of
the bill aimed at aiding victims of Hurricane Katrina.
At the same time, both chambers are finalizing details on
a continuing resolution that will take the government through November 18,
guaranteeing a target Thanksgiving
adjournment. But with continuing debate over two Supreme Court nominees, unfinished
appropriations bills and the emergency supplemental spending bill to take care
of drought, Katrina and now Hurricane Rita, some speculate there will be post-Thanksgiving
session. The following are highlights of Senate floor action on ag appropriations.
Return to top
Senate Takes First Shot at Japanese by Banning Beef Imports
A USDA proposed rulemaking aimed at allowing Japanese boneless
beef to enter the U.S. was blocked when the Senate adopted an amendment to
the
FY2006 appropriations bill suspending all funding to complete the rulemaking
until the Japanese ease their ban on U.S. beef imports. The amendment, offered
by Sen. Ben Nelson (D-NE), was adopted 72-26. No similar provision, however,
is in the House spending bill, so conference action will be needed. The amendment
withholds the USDA funding “unless the president certifies to Congress
that Japan has granted open access to Japanese markets” for U.S. beef.
The measure was the long-threatened action by Congress, frustrated
with Japanese maneuvers that continue to delay the October, 2004, agreement
to resume trade
in beef from animals under 20 months old.
However, last week a Japanese professor who heads a research group under Japan’s
Food Safety Commission released a draft report questioning the safety of U.S.
beef because of “inadequate” feed regulations.
Return to top Industry Heads Off Move to Legislative BSE Feed Rule
A prospective amendment to the FY2006 ag appropriations bill
aimed at legislating FDA’s BSE feed rule was thwarted through a well-coordinated
industry opposition campaign. Sen. Maria Cantwell (D-WA) contemplated an amendment
that would have banned poultry litter, plate waste, and all blood and blood
products from feed, while requiring feed mills handling restricted materials
to dedicate
facilities, equipment and production lines, as well as packaging of feeds containing
restricted material. Over 10 groups with significant interest in the BSE issue,
including the American Feed Industry Assn., American Meat Institute, National
Meat Assn., National Grain & Feed Assn. and American Farm Bureau Federation
signed a letter to the full Senate opposing Cantwell’s intent. Cantwell
did not offer the amendment.
Return to top Animal
Rights Amendments Accepted
Three amendments promoted by the Humane Society of the United States (HSUS),
the nation’s largest animal rights group, were accepted during floor
debate on the FY2006 ag appropriations bill. A pair of amendments was offered
by Sen. Daniel Akaka (D-HI), one to ban all downed animals – not just
cattle and/or dairy -- from the food chain, and a second to withhold USDA funding
from research facilities, including land grant universities, who purchase research
animals from USDA-licensed Class B animal dealers. Akaka’s amendments
received neither debate nor a recorded vote, but were accepted on a voice vote.
A third amendment, language from Sens. John Ensign (R-NV)
and Robert Byrd (D-WV), mirrors House ag appropriations language, and would
withhold funding
from USDA to inspect horses destined for slaughter. But while HSUS and other
animal rights groups celebrated “the death knell” for horse slaughter
in the U.S., it appears the single U.S. company operating horse slaughter facilities
likely will see no change in operations as USDA rules allow the company to
pay the cost of inspection.
Return to top
FDA Provisions Added to Senate Agriculture AppropriationsIn completing FY2006
agriculture appropriations the Senate
avoided several significant FDA-related amendments.
The highly charged issue of legalizing prescription
drug importation was dodged because an amendment, filed by Sens. David
Vitter (R-LA)
and Tom Coburn (R-OK), to prohibit FDA from using funds to prevent
importation was not offered. Reportedly, a significant number of senators
had indicated if an amendment related
to Rx importation were offered, they would support the addition of
provisions that would require a secretarial certification of safety
and cost-effectiveness.
This issue now must be resolved in a House-Senate conference, as the
House-passed bill includes the prohibition: “None of the funds
appropriated or otherwise made available by this Act for the Food and
Drug Administration may be used under section 801 of the Federal Food,
Drug, and Cosmetic Act to prevent an individual not in the business
of importing a prescription drug within the meaning of section 801(g)
of such Act, wholesalers, or pharmacists from importing a prescription
drug which complies with sections 501, 502, and 505.” The conferees
will have the option of dropping the House provision altogether or
modifying it, depending on what can be agreed to.
House and Senate
discussions to resolve differences between the two bills are expected
to begin immediately, with the hope of final passage
by the end of the fiscal year.
FDA-related amendments adopted by the Senate include:
• Sen. Richard Durbin (D-IL) and others, to prohibit FDA from
using its funds to grant waivers of financial conflict of interest
requirements
for voting members of advisory committees unless the rationales for
waivers and nature of the conflict of interest are disclosed on FDA’s
website at least 15 days before panel meeting.
• Sen. Robert Bennett
(R-UT), to prohibit FDA from using its funds to review, clear, or approve
a contact lens unless the manufacturer certifies that “it
makes any contact lens it produces, markets, distributes, or sells available
in a commercially reasonable and non-discriminatory manner directly to and
generally within all alternative channels of distribution.” This includes
mail order companies, Internet retailers, pharmacies, buying clubs, department
stores, and mass merchandise outlets.
• Sen. Christopher Dodd (D-CT), to require
FDA to issue, in one year, a final monograph for OTC sunscreen products,
including UVA and UVB labeling, that
would pre-empt any state labeling requirements.
• Dodd, expressing the sense
of the Congress that FDA should issue this final monograph.
FDA-related amendments filed, but not offered
and thus not considered by the Senate and not part of the final bill
included:
• Sen. Patty Murray (D-WA), to transfer $15 million from the Office
of the FDA Commissioner to the Office of Over-the-Counter Drug Evaluation.
• Murray, to transfer $10 million from the Commissioner’s Office
to the CDER Office of Drug Safety, for post-market surveillance activities.
• Murray, to reduce funding of the Commissioner’s Office by
$5 million.
• Murray, prohibiting the expenditure of funds for a rulemaking related
to switching the Plan B contraceptive product to OTC status (not including
the 60-day public comment period that began August 26, 2005).
• Sen. Russ Feingold (D-WI), to require a report by FDA on the prevalence
of unsafe pesticide residues in ginseng and ginseng-containing products,
including a comparison between foreign and domestic ginseng.
• Sen. Hillary Clinton (D-NY) and others, to withhold $10 million
from the Office of the Commissioner as of January 16, 2006, until the
agency either has approved or disapproved OTC sale of Plan B.
• Clinton and others, to withhold $10 million from the Office of the
Commissioner until FDA has complied with congressional requirements
that condoms be labeled to indicate they are not effective in preventing
human papilloma virus infection. (A similar amendment was filed by
Sen. Tom Coburn (R-OK).)
• Sen. Sam Brownback (R-KS), to prohibit the use of FDA funds for
activities related to clinical trials where the protocol requires a
placebo or no-treatment control, in studying products for serious or
life-threatening conditions, if approved alternative therapies available.
• Brownback, to withhold funds until the Commissioner testifies regarding
when FDA will respond to the Citizen Petition requesting a stay of
approval of Mifeprex (RU-46).
• Sen. Lisa Murkowski (R-AK), to allow interstate shipment and sale
of bottled water, without regard to whether the water meets specific
registration or licensing requirements for states which it is shipped.
• Sen. James Inhofe (R-OK), to prohibit use of FDA funds to allow
importation of drugs from countries that are communist, socialist,
have socialized healthcare, or support terrorism.
Return to top
GAO Study of Advisory Committee Waivers Requested
In connection with an amendment adopted to the agriculture
appropriations bill related to waivers granted by FDA to advisory panel
members who
may have a conflict of interest (see previous article), Sens. Mike
Enzi (R-WY), Ted Kennedy (D-MA), and Dick Durbin (D-IL) jointly requested
the Government Accountability Office (GAO) conduct a study of such
waivers.
Stating they are “concerned about the process that supports
FDA’s decisions to waive conflicts of interest rules for scientists
with financial ties to the manufacturers of the products under consideration,
or their competitors,” the senators asked GAO to examine this
process.
In discussing the request, the senators echoed the words of Durbin
when he offered his amendment on the appropriations bill, regarding
the need for consumers to be certain that decisions made by advisors
to FDA are based on good science and not influenced by potential financial
gains. The senators specifically referred to recent advisory committees
that considered the risks and benefits of the COX-2 inhibitors and
silicone breast implants. In both of these cases, allegations were
made and concerns raised about advisory committee members having financial
ties to the companies that manufacture these products.
Representatives of FDA and the regulated industries have expressed
concern about congressional attempts to preclude conflict of interest
waivers. They have argued for FDA’s need to access, for its advisory
panels, targeted and often scarce expertise related to matters before
the agency. Often, most or all of those with this expertise also have
provided that expertise, in some capacity, to the regulated companies.
Under some congressional proposals, all of those people essentially
would have been prevented permanently from advising FDA.
Return to top
Medicare Prescription Drug Coverage Moves Forward; Medicaid Changes
Hang in Balance Despite rumblings on Capitol Hill about spending associated with the
recent hurricanes, combined with calls to delay implementation of the
new Medicare Part D prescription drug benefit, the benefit is moving
forward.
In a press conference Friday morning, Centers for Medicare & Medicaid
Services (CMS) Administrator Mark McClellan announced approval of private
plans to provide prescription drug coverage. He also released names
of plans available in various parts of the country, stating multiple
plans will be available in every state and at least one plan will be
available with a monthly premium less than $20. Detailed information
about the plans, including descriptions of the drug formularies, will
be available at the beginning of October.
Meanwhile, Reps. Jeff Flake (R-AZ), Jeb Hensarling (R-TX) and Mike
Pence (R-IN) have introduced legislation (H.R.3870) to delay for two
years implementation of the new benefit for all but the lowest income
beneficiaries. Similar suggestions have been made by groups of fiscal
conservatives. The White House reportedly has been approached to get
behind the effort, which it has declined to do. The rationale for delaying
the new benefit is the belief that the cost, coupled with the unanticipated
emergency spending for hurricane relief efforts, is excessive spending
for which there are no offsets. Members concerned about this continue
to urge congressional leadership and the White House to propose viable
spending cuts in other programs, but proposals for such cuts have not
been forthcoming.
In addition, contentious discussions continue regarding
earlier-proposed reductions in spending for the Medicaid program. Both
House and Senate
budget resolutions call for Medicaid savings on the order of $10 billion.
Faced with enormous need for health services by uninsured, low-income,
and displaced individuals in areas affected by Hurricane Katrina (Hurricane
Rita’s impact potentially will exacerbate this), many in Congress
seem no longer to have the stomach for Medicaid cuts. On the contrary,
legislation has been introduced to increase federal assistance to affected
states to help with their Medicaid costs and CMS has provided waivers
to allow states to assist displaced persons through their Medicaid
programs.
H.R.3698, the Temporary Medicaid Disaster Relief Act
of 2005, would allow states to use Medicaid to provide health services
to Katrina
victims for one year, increase federal matching funds to 100% and continue
drug coverage under Medicaid for individuals eligible for both Medicaid
and Medicare whose drug coverage otherwise would be transferred to
Medicare Part D as of Jan. 1, 2006). The bill also provides for
additional changes designed to ease hurricane survivors’ access
to Medicaid and to allow states to provide it to their own citizens
or to those displaced to their state.
Senate Finance Committee Chair
Chuck Grassley (R-IA) has introduced S.1716 with 11 bipartisan cosponsors,
including the committee’s
ranking Democrat, Sen. Max Baucus (D-MT). This bill also increases
federal matching funds for providing Medicaid to Katrina survivors,
as well as require states to provide health care under Medicaid for
eligible survivors and make a number of other changes related to Medicaid
and other programs, limited to five to 10 months and to certain affected
areas and individuals. As currently drafted, the legislation is focused
on Louisiana, Mississippi, and Alabama and on Hurricane Katrina.
Whether
other Medicaid changes, including longer term reforms recommended
by the Administration and National Governors Association, will occur
in this congressional session is unclear, as is the broader question
of whether Congress will complete it Budget Reconciliation process.
Return to top
Committee Launches Inquiry into Use of NIH Grants
On September 22, House Energy & Commerce Committee
Chair Joe Barton (R-TX) announced the committee, with its oversight
and investigations
subcommittee chaired by Rep. Ed Whitfield (R-KY), has asked the HHS
Inspector General (IG) to look into the possible misuse of National
Institutes of Health (NOH) funds by grant recipients. The committee’s
statement refers to recent settlements between the Justice Department
and Harvard University, Johns Hopkins University, and the Mayo Clinic,
associated with claims that the institutions misused grant funds. The
letters to the IG indicate a concern that the problem may continue
and be broader than just a few institutions.
Two matters are raised specifically in the requests to the IG: use
of grant funds to pay “unreasonable” compensation to graduate
students and grantees’ reporting to NIH a number of research
activities that exceeds what they actually perform.
One letter refers to a 1994 IG report on compensation
practices at three institutions, including the University of California,
which concluded “unreasonable
compensation” was charged to federal grants. The committee letter
suggests this problem may persist, at least at the University of California,
Davis. Specifically, the letter states the committee’s view the
current rate of $75-$89 per hour in salary and tuition allowance allow
graduate students to earn $150,000 per year or more. This amount, the
letter says, appears substantially higher than what is paid to postdoctoral
researchers for the same work, and could be a significant misuse of
federal grant funds. The committee asks the IG “to determine
if federal taxpayer dollars have been used by state universities to
compensate graduate research assistants for tuition remission rather
than for their actual work on programs funded by the NIH” and
to examine whether this is an illegal and/or inappropriate use of federal
funds.
In its second request, the committee asks the IG to
look at the numbers of projects or activities described by applicants
for clinical research
center grants and to determine whether the activities actually performed
under the grant are fewer than these projections. In addition, the
letter suggest, the IG “may also want to consider designing this
audit to capture other kinds of discrepancies, such as false statements,
improper accounting, improper charges to NIH grants, and even fraudulent
double-billing of the Medicaid program for in-patient fees charges
incurred in connection with protocols performed under these clinical
research center grants.”
Return to top
Hearing Scheduled on Direct-to-Consumer Drug Advertising
The Senate
Special Committee on Aging has scheduled a hearing for Thursday,
September 29, on “The Impact of Direct-to-Consumer Drug Advertising
on Seniors' Health and Health Care Costs.” A witness list has
not yet been provided. Return to top
FDA Feed Rule Changes Coming Very Soon
Ambiguous statements by then-FDA Commissioner Lester
Crawford about the timing and content of the FDA feed rule fueled significant
media attention – and interpretation – this
week. After the dust settled, however, Crawford had revealed less than
imagined by most reporters.
Crawford, speaking to a Consumer Federation of America’s
food safety meeting, gave brief remarks on FDA post-Katrina efforts,
as
well as on other pending issues at FDA. In talking about the timing
of a proposed rule to modify FDA’s ruminant feed rule, Crawford
said publication is “imminent.” When pushed to reveal details
of the proposal, Crawford declined.
These remarks, combined with last month’s Crawford speech to
food technologists in Baltimore, provide the following information:
The proposed rule will publish very soon – perhaps as early as
next week -- as it’s known the proposal is undergoing final Office
of Management & Budget review at this writing. It will very likely
concentrate on removal of certain limited specified risk materials
from feed, e.g. brains and spinal cords from older animals. Other areas
upon which it may touch will be the future of blood/blood products,
plate waste and poultry litter feeding and treatment of deads and nonambulatory
livestock.
As to how closely the FDA proposal will resemble the Canadian proposed
rule on ruminant feeding is a matter of much conjecture. However, it’s
likely that in the spirit of “harmonization” and based
on evolving science and animal testing, both nations will modify their
original public statements and attempt to arrive at rules which allow
North America to be viewed as a single market with near identical regulatory
processes.
Return to top
Ag Losses from Katrina, Drought Could Top $2 Billion;
Disaster Package to Carry Farm Money, Rita a Big Unknown
USDA said this week farm losses directly attributable to Hurricane
Katrina will likely top $900 million. Adding losses expected from the
prolonged drought across the Midwest, this figure could surpass $2
billion, with drought losses estimated at $1.3 billion. Hurricane damage
included limited cotton, sugarcane and dairy product losses in Louisiana,
Alabama and Mississippi.
About 10,000 cattle and several million chickens were killed in the
storm, USDA said. Short-term livestock losses were estimated to be
about $30 million, with dairy farmers losing about $3 million worth
of milk.
Sen. Dick Durbin (D-IL) issued a press release this
week saying Sen. Thad Cochran (R-MS), chair of the Senate Appropriations
Committee,
has agreed to include drought assistance in the upcoming congressional
relief legislation. Durbin said USDA numbers show corn and soybean
losses in Illinois alone are more than $792 million. Durbin led a bipartisan
group of midwestern senators who tried to add $2.7 billion to the
agricultural appropriations bill to provide drought aid. Cochran’s
assurance resulted in withdrawal of the Durbin amendment.
Both houses of Congress are expected to begin putting together emergency
funding bills as soon as better estimates of actual damage are in hand
by government accountants. Hurricane Rita’s impact on the amount
of federal spending is unknown. A huge debate is raging now over how
to pay for the unprecedented amounts of money being discussed, running
as high as $300 billion, say some. A growing centrist movement in both
chambers is demanding that offsets – cuts to existing programs – be
used to help cover the cost.
Meanwhile, Sen. Charles Grassley (R-IA), chair of
the Senate Finance Committee, suggested this week that an across-the-board
freeze in federal
spending for at least one fiscal year be used to offset the costs,
adding he would oppose any move to raise taxes to pay for disaster
relief and cleanup.
Return to top
USDA Sets Conservation Planning Sign-Up Pilot
Nine states will participate in a conservation planning
pilot sign up program, designed to emphasize for farmers the need
to be better
prepared to apply for conservation programs and to comply with state,
local and federal environmental regs.
Announced by USDA Deputy Secretary Chuck Conner at
the Oklahoma City Farm Bill Forum, the states in which the pilot will
run are California,
Colorado, North Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island,
Texas and Wyoming. Details of the program can be found at www.nrcs.usda.gov/programs/cta.
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.1735
Sen. Maria Cantwell (D-WA) introduced a bill to improve the Federal
Trade Commission’s ability to regulate “price-gouging” during
energy emergencies.
S.1752
Sen. Saxby Chambliss (R-GA) offered legislation to reauthorize the
U.S. Grain Standards Act.
H.R.3846, H.R.3847 & H.R.3848
Rep. Mark Green (R-WI) introduced three bills to extend the Milk Income
Loss Contract Program.
H.R.3849
Legislation proposed by Rep. Frank Lucas (R-OK) would implement pesticide-related
obligations of the U.S. under the international conventions or protocols
known as the PIC Convention, the POPs Convention, and the LRTAP POPs
Protocol.
H.R.3857
A bill offered by Rep. Bob Goodlatte (R-VA) would “simplify” the
process for admitting temporary alien agricultural workers under the
Immigration and Nationality Act.
H.R.3861
Rep. Fortney “Pete” Stark (D-CA) introduced a bill to provide
extended and additional protection to Medicare beneficiaries who enroll
for the Medicare prescription drug benefit during 2006.
H.R.3870
Rep. Jeff Flake (R-AZ) offered legislation to delay for two years implementation
of the Medicare prescription drug benefit for individuals who are
not lowest-income subsidy eligible individuals.
H.R.3874
A bill introduced by Rep. Jeff Fortenberry (R-NE) provides for tax
exempt qualified small issue bonds to finance agricultural processing
property.
H.R.3889
Rep. Mark Souder (R-IN) proposed legislation to regulate further and
punish illicit conduct relating to methamphetamine.
Return to top
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