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July 29, 2005

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In this Issue


Congress Wraps Up for Summer Recess


House Passes Controlled Substances Bills


Senate Preparing for September Stem Cell Debate


Senate Committee Reports Contact Lens Bill


House Passes All-Schedules Reporting Act


Patient Safety Legislation Becomes Law


New FDA Commissioner has Baptism By Fire; Makes Key Management Changes


Medical Device User Fees Legislation Cleared for White House


Senate Judiciary Reports Methamphetamine Bill


USDA Testing Tissue from Suspect Cow


On Squeaker Vote, House Approves CAFTA

Congress Approves Energy Conference Report


Senate, House to Finally Pass Highway Bill Before Recess


FDA Bans Poultry Antibiotic on Human Health Concerns


USDA, DHS, FDA Join States, Industry on Agroterror Protection


USDA Says Farm Production Spending Up 5.1% In 2004


New Bills

 

Congress Wraps Up for Summer Recess

With Congress scheduled to leave for August recess the end of this week, the House and Senate kept themselves busy passing numerous bills both on the floor and in committee. The House has passed all 12 appropriations bills, with the Senate completing committee mark up on all bills. Yet many key appropriations bills, including the agriculture and the labor, health & human services bills, have yet to be passed by the Senate.

Congress will be returning after Labor Day, with the Senate set to start September 6 on consideration of the nomination of John Roberts to the United States Supreme Court.

Inside Track will not be published during August.

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House Passes Controlled Substances Bills

On July 27, the House passed S. 45 and S. 1395, clearing the bills for the President.

S. 45 amends the Controlled Substances Act (CSA) to remove the patient limitation on prescribing opiate addiction therapies by physicians in group practices. Under current law, physicians are limited to treating 30 patients at a time. This limitation applies to both individual physicians and groups, thus resulting in limiting large group practices with dozens or hundreds of doctors to treating the same number of patients as an individual physician in a solo practice. S. 45 clarifies while each physician in a group practice will be limited to 30 patients, that limit is not applicable to the group as a whole.

The Senate passed S. 45 by unanimous consent last week and the House Energy & Commerce and Judiciary Committees had already reported H.R. 869, an identical bill. S. 45 is sponsored by Sens. Carl Levin (D-MI), Orrin Hatch (R-UT), Joseph Biden (D-DE), Charles Grassley (R-IA), Dick Durbin (D-IL) and Hillary Clinton (D-NY). H.R. 869 is sponsored by Rep. Mark Souder (R-IN) and a bipartisan group of 44 others.

Souder, speaking in support of the bill, noted the importance of a fairly new FDA-approved therapy, buprenorphine, stating the current 30-patient cap has unnecessarily limited use of this product. He described this as “a major new tool to fight addiction [that] does not have a high potential for misuse or fatal overdose.”

He listed numerous organizations supporting the legislation, including the American Medical Assoc., the National Assoc. of State Alcohol and Drug Abuse Directors, the Assoc. of American Medical Colleges, the American Psychiatric and Psychological Assoc., Kaiser Permanente, the American Group Practice Assoc., and the City of New York. Also speaking in favor of the bill were Reps. Nathan Deal (R-GA), Sherrod Brown (D-OH), Michael Capuano (D-MA) and Elijah Cummings (D-MD). The bill passed the House by a recorded vote of 429-0.

S. 1395, the Senate companion to H.R. 184, the Controlled Substances Export Reform Act, amends the CSA to allow in specified circumstances the re-export of controlled substances. The changes in law will allow a manufacturer to export a controlled substance prescription drug to a non-U.S. location, with further export from that location to another. Under current law, each export from the U.S. can be only to a single country, with no possibility of re-export.

Supporters of the legislation point out it will allow companies to operate more efficiently and cost effectively by shipping larger quantities of the product to one overseas country and, from there, to ship smaller quantities to additional purchasers. All shipments must be reported to the DEA in advance and afterwards.

H.R. 184 is sponsored by Rep. Joseph Pitts (R-PA) and a bipartisan group of nine others; S. 1395 is sponsored by Hatch and Biden. S. 1395 passed the Senate by unanimous consent July 13, and H.R. 184 had been reported by the House Energy & Commerce and Judiciary Committees June 9 and July 11, respectively. S. 1395 passed the House by voice vote.

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Senate Preparing for September Stem Cell Debate

On July 29, Senate Majority Leader Bill Frist (R-TN) announced on the Senate floor his support for stem cell research and H.R. 810, the Stem Cell Enhancement Act, and a vote on the legislation when Congress returns from its August recess.

The Senate is planning on bringing H.R. 810 to the floor as part of a package of six or now possibly seven bills. One of these is a bill from Sen. Sam Brownback (R-KS) that would ban human somatic cell nuclear transfer research.

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Senate Committee Reports Contact Lens Bill

The Senate Health, Education, Labor, & Pensions (HELP) Committee reported July 27, S. 172, a bill to amend the Food, Drug & Cosmetic Act (FDCA) to require all contact lenses be regulated as medical devices. The bill has been placed on the Senate calendar.

Sponsored by Sens. Mike DeWine (R-OH), Ted Kennedy (D-MA) and a bipartisan group of eight others, the bill would amend section 520 of the FDCA to deem all prescription and non-prescription contact lenses medical devices. The bill is a response to concerns about the marketing and sale of non-corrective lenses, including colored and other decorative lenses, without prescriptions or any oversight of an eye-care professional.

The bill’s findings assert eye injuries have been associated with these lenses. FDA has argued, in response to several congressional inquiries over the past two years, the agency does not have the authority to regulate non-corrective lenses. These lenses do not technically meet the definition of “medical device” since they do not have the purpose to prevent or treat a disease or other medical condition. S. 172 would provide this authority without otherwise broadening the definition of medical device.

H.R. 371, the companion to S. 172 sponsored by Rep. John Boozman (R-AK) and 60 others, has not yet been considered by the House Energy & Commerce Committee, to which it is referred.

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House Passes All-Schedules Reporting Act

By voice vote, the House passed H.R. 1132 July 26, a bill to require the Secretary of HHS to award grants to states for electronic systems to monitor the dispensing of prescription drugs that are controlled substances in Drug Enforcement Administration (DEA) Schedules II, III, and IV. A number of states already have such activities using funds from Department of Justice appropriations. H.R. 1132 specifically authorizes such a grant program in law, as opposed to leaving it to the annual appropriations process to obtain funding.

The bill would put in place standards states would need to put in place to qualify for the funds. Among these are states must require dispensers to report no later than one week after dispensing a controlled substance to a patient or a research subject and must establish and operate electronic searchable databases containing this information. The state information could be shared with entities such as practitioners, law enforcement officials, other state programs and various federal health and controlled substance/drug enforcement programs. A uniform electronic format would be established so state programs would be interoperable.

In comments on the House floor, Representatives on both sides of the aisle expressed support for the bill, including bill sponsors Rep. Edward Whitfield (R-KY), Charlie Norwood (R-GA) and Frank Pallone (D-NJ) and the chair and ranking Democrat on the Energy & Commerce health subcommittee, Reps. Nathan Deal (R-GA) and Sherrod Brown (D-OH). They cited the need for such activities to address the nation’s growing problem of prescription drug abuse. H.R. 1132 is sponsored by 35 House members of both parties.

Rep. Ed Markey (D-MA), speaking in opposition, expressed concern the bill does not include sufficient patient privacy protections. In particular, he said the bill would allow for systems that do not prevent disclosure of personal medical information about individuals receiving prescriptions for these substances as part of their legitimate medical care.

Meanwhile, a similar Senate bill, S. 518, has been reported by the Health, Education, Labor, & Pensions (HELP) Committee. S. 518 has bipartisan support from the principal sponsor Sen. Jeff Sessions (R-AL) joined by HELP committee ranking member Sen. Ted Kennedy (D-MA) and a bipartisan group of six others. While there are differences between S. 518 and H.R. 1132, reportedly they are not so great as to prevent a compromise emerging relatively easily and swiftly.

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Patient Safety Legislation Becomes Law

The Patient Safety & Quality Improvement act passed by the Senate July 21 and by the House July 27, was signed by the President July 29. The bill is hailed as being a viable and necessary response to growing concerns about patient illness, injury, and death resulting from medical errors. Sen. James Jeffords (I-VT) sponsored the Senate bill S. 544 with the companion bill, H.R. 3205, sponsored by Rep. Michael Bilirakis (R-FL).

Congressional action on this matter followed on the heels of a report by the National Academy of Sciences noting significant action was called for, in light of growing numbers of patients injured through avoidable mistakes in healthcare settings. The legislation requires the following:

• the HHS Secretary to maintain a database network with patient safety data that is searchable, but protects patient privacy;

• establishes a system of Patient Safety Organizations (PSO) to which providers can disclose medical errors on a voluntary basis, including information that identifies reckless behavior as well as information identifying mistakes, but without identifying patients;

• protects providers who voluntarily disclose information in good faith;

• provides for research using the data collected by the PSOs, to allow better understanding of how to prevent or minimize errors; and,

• and requires the development of standards that promote the electronic exchange of information.

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New FDA Commissioner has Baptism By Fire; Makes Key Management Changes

Newly confirmed by the Senate, FDA Commissioner Dr. Lester Crawford made his first official appearance July 26 before the House Appropriations subcommittee on agriculture, rural development, Food & Drug Administration, & related agencies. This could have been the routine appropriations testimony of an agency head, but since the House already passed the appropriations bill, this was a somewhat unusual juxtaposition of events. In fact, House action withheld funds from FDA because Crawford had not presented the agency’s routine budget testimony prior to bill action. Several House members referred, during House debate on the FDA appropriations bill, to their intention to withhold these funds until hearing from Crawford.

While the testimony discussed both the general budget numbers and priorities for FDA, it also included a strong focus on what members wanted to discuss – drug safety. Crawford pointed to a number of actions taken by the agency or under way to enhance the agency’s approach to drug safety, including the transparency of its actions. He pointed, for example, to the newly established Drug Safety Oversight Board and the proposed Drug Watch web page. His testimony also emphasized other drug safety actions that pre-dated the recent congressional focus on the topic.

Members who questioned Crawford about drug safety (especially ranking subcommittee member Rep. Rosa DeLauro (D-CT)) were not satisfied, and criticized the FDA for not being more aggressive. In particular, they were critical of Crawford for allegedly not being straight with Congress about FDA’s need for additional legal authority. In response to repeated demands for a straighter answer and quotes from various FDA officials who had either testified before Congress or spoken to the press, Crawford finally stated he would re-evaluate and think further about whether FDA needs additional authority to require post-market studies and/or require specific product re-labeling. He said he would “work with” members on these and related matters, moving forward.

Among Crawford’s actions since his confirmation is the establishment, announced July 29, of a new FDA council to coordinate the Management, Strategic Planning, and Regulations Policy Councils. He named Dr. Janet Woodcock head of the council, in her new capacity as deputy commissioner for operations. She has been acting in that capacity for a significant period of time and is the former head of the FDA Center for Drug Evaluation & Research.

Crawford also announced the permanent appointment of Dr. Murray Lumpkin as deputy commissioner for international affairs; the appointment of Patrick Ronan, currently associate commissioner for legislative affairs, as chief staff officer; and the hiring of Dr. Scott Gottlieb as deputy commissioner for medical and scientific affairs. Woodcock will continue to oversee the FDA’s Critical Path and 21st Century GMPs initiatives and Lumpkin will continue to oversee combination products and pediatric therapeutics.

In describing the new structure and appointments, Crawford said, “This new structure represents an efficient and compact central organization that bespeaks our commitment to advance and protect the public health by doing our jobs wisely and well.”

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Medical Device User Fees Legislation Cleared for White House

On July 26, the House passed H.R. 3423, the Medical Device User Fee Stabilization Act; the Senate followed passing the bill July 27, and clearing it to be signed into law. The legislation corrects some problems with the existing device user fee program structure in terms of the so-called “appropriations trigger” for the collection of fees. In addition, the bill places a limit of 8.5% on the amount application fees can increase and modifies the small business definitions.

Under the new provisions, a business with $30 million or less gross receipts or sales will be entitled to one free pre-market application of 510(k) notification. Businesses with $200 million or less revenue may be entitled to fee reductions.

Under current law, FDA is required to report to Congress annually on the extent to which the agency has met its user fee performance goals and provide a financial accounting of how it has spent the user fee income. H.R. 3423 adds several specific requirements to what must be included in the annual reports, including: (1) information on the number and types of applications and 510(k) notifications received from, and the amounts of fees paid by small businesses, categorizing these business in $10 million increments up to $100 million, and (2) certification by the Secretary that the FDA appropriation for non-user-fee activities is not less than the FY02 appropriation multiplied by the annual adjustment factor.

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Senate Judiciary Reports Methamphetamine Bill

The Senate Judiciary Committee reported July 28, S. 103, the Combat Meth Act, and the bill was placed on the Senate calendar. The legislation is sponsored by Sens. Jim Talent (R-MO), Dianne Feinstein (D-CA) and a bipartisan group of 34 others. The bill would amend the Controlled Substances Act (CSA) to add pseudoephedrine to the Drug Enforcement Administration’s (DEA) Schedule V controlled substances list, and to add that non-prescription psuedoephedrine-containing products must be sold, dispensed, and distributed only by a licensed pharmacist or pharmacy technician.

Essentially, this means pseudoephedrine-containing over-the-counter drugs must be sold “behind the counter” in retail stores. In addition, the bill would require every transaction be recorded and purchasers provide photo identification. Each purchaser of a pseudoephedrine-containing OTC product would be limited to no more than 9 grams per month. DEA would be authorized to exempt products from these requirements upon a determination the product is not being used in the illegal manufacture of methamphetamine or other dangerous substance.

In addition, the “behind-the-counter” requirements could be changed, by regulation, if DEA determines “the absence of a pharmacy causes a hardship for the community” and other procedures would accomplish the goal. Finally, a manufacturer could provide evidence to DEA the product containing pseudoephedrine is formulated to prevent its use to manufacture methamphetamine. In such a case, that product could be exempt from the Schedule V requirement.

Other provisions of the legislation include the following:

• authorization of funds to train state and local law enforcement officials to investigate and prosecute methamphetamine offenses;

• expansion of community policing programs;

• authorization of grants to develop programs for rapid response on behalf of drug-endangered children and for methamphetamine abuse treatment;

• requirement to allocate Justice Department funds to train special U.S. attorneys, and

• authorization of Justice Department grants for monitoring methamphetamine precursors.

A related House bill, H.R. 314 introduced by Rep. Roy Blunt (R-MO) and 45 others, is pending before the House Judiciary Committee.

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USDA Testing Tissue from Suspect Cow

Brain tissue samples from a suspect dairy cow which died on-farm in April are on their way to Weybridge, England, for testing for BSE, USDA announced this week. The cow, at least 12 years old, died while calving. Samples were taken by a private veterinarian who burned the carcass, keeping it out of the food/feed chain, but forgot to send the samples to USDA.

While the tissue samples were not forwarded to USDA until this month, and because the vet treated the samples with formalin, a preservative, testing of the samples using immunohistochemistry (IHC) and Western Blot tests were inconclusive. Results from retesting at Weybridge and retesting at USDA’s Ames, Iowa laboratory are expected sometime next week.

Dr. John Clifford, USDA’s chief veterinarian, said during a press briefing this week initial testing at Ames, Iowa indicated there may be the presence of BSE, but the samples did not appear to be typical BSE, lacking normal prion distribution. Since the second case of BSE in the U.S., that of a Texas cow, USDA no longer allows formalin preservation of samples, requiring them to be shipped immediately. Clifford said the Ames testing showed atypical BSE prion distribution in the stained slides used in testing. France, Japan, Belgium and the United Kingdom have all reported cases of atypical BSE, and USDA has quietly begun further animal studies on the Texas cow samples.

Clifford and other USDA officials have said the latest case should not affect on-going trade discussions with Japan and others.

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On Squeaker Vote, House Approves CAFTA

The House approved the Central American Free Trade Agreement (CAFTA) this week 217-215, a two-vote margin that likely will become a one-vote margin once a glitch in the House voting system is ironed out. The White House and most of agriculture are celebrating the victory.

President Bush worked the phones right up to the vote, convincing two hesitant Republican members to vote in favor of the agreement, but failing to convince half a dozen freshman members who’d campaigned on opposition to CAFTA. The White House also convinced the House leadership to hold off voting on the highway reauthorization conference report to keep members around for the CAFTA vote. In all, 42 members voted against their party’s position on CAFTA.

The win comes after the Administration made pledges on issues ranging from southern states’ textile concerns to labor protections for Central American workers. Also contributing to the win was the Democratic leadership’s decision not to hold its members to a straight party-line vote.

The vote margin will shrink to a single vote once the House Clerk’s office finishes its check on an apparent electronic voting malfunction. Initially, Rep. Charles Taylor (R-NC) was recorded as not voting, but it turns out Taylor cast a “no” vote at the same time Rep. Howard Coble (R-NC) voted against the pact. The system only recorded Coble’s vote. Another Republican who would have voted against the pact, Rep. Jo Ann Davis (R-VA), didn’t vote because she was on her way to her district for a Boy Scout Jamboree event, avoiding a tie vote on CAFTA.

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Congress Approves Energy Conference Report

The House and Senate this week met their obligation to complete work on the comprehensive energy package before the August recess, approving the energy bill conference report. The President repeatedly urged Congress to complete the energy package before they leave for August recess.

Conferees dumped out nearly all of the most controversial issues, including House-approved language granting gasoline additive MTBE manufacturers liability protection; House language allowing drilling in the Arctic National Wildlife Reserve, and compromised on the Renewable Fuel Standard (RFS), agreeing diesel refiners will be blending 7.5 billion gallons of alternative fuels into gasoline and diesel fuel by 2012.

The 7.5 billion gallons is higher than many expected given the House originally approved a 5-billion-gallon RFS standard and the Senate approved 8 billion gallons. Opponents of the relatively high number contend it could drive crop prices – primarily corn for ethanol and soybeans for biodiesel – much higher over the life of the bill, negatively impacting livestock and poultry feeders and other users of those crops.

House Agriculture Committee Chair Bob Goodlatte (R-VA) said in a formal statement, “I will work hard to ensure that we continue to have an affordable and ample supply of feed for livestock and poultry producers.”

The package also contains $14.5 billion in various tax breaks and incentives to energy companies, including several sections which are meant to accelerate refining of biodiesel, either from first-use vegetable oils and animal fats or from recycled vegetable oils and other waste biomass feedstocks.

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Senate, House to Finally Pass Highway Bill Before Recess

The on-track, off-track omnibus highway reauthorization conference committee process appears to finally be coming to an end, as the House and Senate are set to act to reauthorize federal highway and commuter programs July 29. The House hoped to vote late on Thursday, July 28, but a last-minute snag derailed the vote.

The federal highway program expired two years ago, and Congress acted to temporarily extend those programs 10 times in the intervening period. The bill, widely acknowledged as carrying more individual member “earmarks” than just about any other bill, will cost $286.4 billion over six years, including one activist group estimate of 5,696 pork barrel projects worth $21 billion.

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FDA Bans Poultry Antibiotic on Human Health Concerns

On July 28, FDA withdrew approval and will no longer allow distribution or use of the antimicrobial drug enrofloxacin. Part of the flouroquinolone family of antibiotics and commercially available as Baytril, the drug owned by Bayer Crop is used to treat bacterial infections in poultry. FDA said the action is in response to data showing the use of the drug in poultry causes resistance to emerge in campylobacter, a bacterium which causes foodborne illness.

The fate of the drug has been before an FDA administrative law judge for several years after FDA asked enrofloxacin sponsors to voluntarily withdraw their products. While one company did, Bayer took the agency to court.

The FDA said its action does not affect other approvals for the drug, but the Animal Health Institute (AHI) said it was “disappointed by the decision…to accept the findings of the administrative law judge. The loss of this product leaves poultry producers without an important tool to treat sick poultry and it will reduce animal health and welfare while increasing animal death and suffering.”

A coalition of activist groups calling itself Keep Antibiotics Working (KAW) praised the FDA action and singled out newly confirmed FDA Commissioner Dr. Lester Crawford for taking the “precedent-setting” action, “the first time that FDA has ever withdrawn an agricultural antibiotic from the marketplace because of concerns about antibiotic resistance affecting human health.”

The withdrawal is effective September 12, and Bayer has 60 days to appeal the action.

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USDA, DHS, FDA Join States, Industry on Agroterror Protection

The states and private industry will join with USDA, FDA and the Department of Homeland Security in a new collaboration to protect agriculture and food processing from the threat of terror attacks. Details on the initiative can be found at www.usda.gov/homelandsecurity.

The Strategic Partnership Program Agroterrorism (SPPA) will create four pilot visits to food and ag facilities in September and October to assess and identify vulnerabilities in the food and ag sectors. Over the next 12 months, teams of federal and state officials will travel to all 50 states to meet with food chain sectors to discuss improvements in protecting production and processing.

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USDA Says Farm Production Spending Up 5.1% In 2004

USDA’s National Agricultural Statistics Service (NASS) reported this week farmers and ranchers spent $210.7 billion on production inputs during 2004, 5.1% more than in 2003. Average expenditure per U.S. farm was $99,983, compared with $94,542 in 2003. The largest contributing factors to the 2004 increase included tractors and farm machinery, up 24.3%; fuels, up 19.4%; fertilizer, up 14%; feed, up 9.1%, and labor, up 5.5%.

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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.4
Sen. Bill Frist (R-TN) proposed legislation to reduce healthcare costs, expand access to affordable healthcare coverage, and improve healthcare and strengthen the healthcare safety net.

S.1503
Frist also introduced the “Healthy America Act of 2005.”

S.1520
Legislation proposed by Sen. Diane Feinstein (D-CA) would prohibit human cloning.

S.1527
Sen. Edward Kennedy (D-MA) introduced a bill to amend the Public Health Service Act with respect to immunizations against vaccine-preventable diseases, including influenza.

S.1532
Sen. Arlen Specter (R-PA) offered a bill to criminalize acts of agroterrorism and increase prevention, detection, response and recovery planning for the United States agricultural industry and food security.

S.1534
Sen. Dick Durbin (D-IL) proposed legislation to reduce the risk to the food supply from intentional contamination.

S.1543
Legislation offered by Sen. Rick Santorum (R-PA) would provide for clinical research support grants, clinical research infrastructure grants, and a demonstration program on partnerships in clinical research.

S.1546
A bill proposed by Sen. Tom Harkin (D-IA) would amend the Food Stamp Act of 1977 to permit food stamp benefits be used to purchase nutritional supplements providing vitamins or minerals.

S.1551
Sen. David Vitter (R-LA) introduced legislation to clarify that the overall trade negotiating objectives of the United States include avoiding provisions in trade agreements that restrict the access of consumers in the United States to pharmaceutical imports.

H.RES.385
Rep. Paul Gingrey (R-GA) offered a resolution to provide for consideration of H.R. 5, a bill to provide for medical malpractice liability reform.

H.R.3408
Rep. Bob Goodlatte (R-VA) offered a bill to reauthorize the Livestock Mandatory Reporting Act of 1999 and to amend the swine reporting provisions of that Act.

H.R.3423
Rep. Joseph Pitts (R-PA) introduced legislation to amend the Federal Food, Drug &Cosmetic Act with respect to medical device user fees.

H.R.3428
A bill offered by Rep. Melissa Hart (R-PA) would amend the Internal Revenue Code of 1986 to repeal the medicine and drugs limitation on the deduction for medical care.

H.R.3444
Rep. Ron Paul (R-TX) proposed a bill to amend the Internal Revenue Code of 1986 to provide credits against income tax for qualified stem cell research, the storage of qualified stem cells, and the donation of umbilical cord blood.

H.R.3502
Rep. Henry Waxman (D-CA) offered legislation to amend the Public Health Service Act with respect to immunizations against vaccine-preventable diseases, including influenza.

H.R.3511
A bill proposed by Rep. Michael Burgess (R-TX) would expand state long-term care partnership programs under the Medicaid program.

H.R.3543
Rep. Nathan Deal (R-GA) offered legislation to eliminate Medicare and Medicaid coverage of drugs when used for treatment of erectile dysfunction.

H.R.3546
Rep. Rahm Emanuel (D-IL) proposed a bill to require public disclosure of average manufacturer prices (AMP) and best prices for prescription drugs.

H.R.3547
A bill proposed by Rep. Jo Ann Emerson (R-MO) would increase the affordability of in-patient drugs for Medicaid and safety net hospitals.

H.R.3553
Rep. Phil Gingrey (R-GA) offered a legislation to prohibit the approval of any drug that “infringes the right to life.”

H.R.3554
Rep. Virgil Goode (R-VA) introduced a bill to amend the crop disaster assistance program for 2003 to clarify the manner in which the Secretary of Agriculture is required to make assistance available to producers under the program.

H.R.3561
Rep. Michael Honda (D-CA) introduced legislation to improve the health of minority individuals.

H.R.3562
A bill proposed by Rep. Darlene Hooley (D-OR) would amend the Specialty Crops Competitiveness Act of 2004 to increase the authorization of appropriations for grants to support the competitiveness of specialty crops, amend the Agricultural Risk Protection Act of 2000 to improve the program of value-added agricultural product market development grants by routing funds through state departments of agriculture and amend the Federal Crop Insurance Act to require a nationwide expansion of the adjusted gross revenue insurance program.

H.R.3566
Legislation proposed by Rep. Steve King (R-IA) would prohibit federal funds from being expended for the payment or reimbursement of drugs prescribed for the treatment of erectile or sexual dysfunction.

H.R.3568
Rep. Tom Latham R-IA) introduced a bill that would amend the Controlled Substances Act to provide for the transfer of ephedrine, pseudoephedrine, and phenylpropanolamine to schedule V of the schedules of controlled substances.

H.R.3570 & H.R. 3571
Rep. Nita Lowey (R-NY) offered legislation to amend the Federal Food, Drug& Cosmetic Act relating to freshness dates on food and requiring foods containing spices, flavoring, or coloring derived from meat, poultry, or other animal products (including insects) bear labeling stating that fact and their names.

H.R.3583
Rep. Anne Northup (R-KY) introduced legislation to clarify the overall trade negotiating objectives of the United States include avoiding provisions in trade agreements that restrict the access of consumers in the United States to pharmaceutical imports.

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