HomeAbout UsServicesClient AchievementsNewsStaffContact Us

May 27, 2005

Back to News

In this Issue


Stem Cell Bill Wins House Support


Senate Committee Reports Rx Drug Monitoring Legislation


House Committees Take Up Pro Sports Steroid Legislation


House Appropriations Committee Approves Ag Spending After Contentious Debate


“Full Funding” to Implement DSHEA Introduced


Congress Responds to Medicaid Coverage of ED Drugs


FDA Reports Progress Against Counterfeit Drugs


FDA Publishes Draft Guidance on “Useful Consumer Information”


National Science Advisory Board for Biosecurity Meeting Scheduled


OIE Shifts BSE Risk Recommendations, Rewrites Recommendations


One More Baby Step By Japan on Beef Trade


Conferees Named to Highway Reauthorization Bill

Senate Committee Approves Comprehensive Energy Package; Showdown Set on Senate Floor and With House Version


Irish Authorities Seize U.S. Shipment of Corn Gluten Feed With Bt-10;
EE Continues Deadlock Over Biotech Corn Imports



CAFTA Battle Heating Up



Grain Standards Act Gets Review in House, Senate


EPA Wants Applications on Methyl Bromide Exemptions For Critical Use


New Bills

 

 

Stem Cell Bill Wins House Support

On Tuesday, “The Stem Cell Research Enhancement Act of 2005,” H.R. 810, passed on the House floor by a vote of 238 to 194. The bi-partisan bill sponsored by Reps. Mike Castle (R-DE) and Diana DeGette (D-CO) received 50 Republican votes, including members who pride themselves on their “pro-life” record. President Bush continues to threaten a veto, including when he held a press conference the day of the vote with children who had been adopted as embryos.

Senate Majority Leader Bill Frist (T-TN) said this week that he wanted to consult with colleagues before bringing the bill up for a vote. Minority leader Sen. Harry Reid (D-NV) called on the Senate to act quickly in passing the bill. But even if Frist does not bring up the measure, Sen. Orrin Hatch (R-UT) said he would force a vote by attaching it as an amendment to another bill. And at least one opponent of the measure, Sen. Sam Brownback (R-KS), indicated that if Frist puts the bill on the agenda, he may try to block it by filibuster. Sen. Arlen Specter (R-PA) responded to Bush’s veto threat in a press conference noting 58 senators signed on to a letter in support of stem cell research last year. This is close to the number that would be needed to over-ride a veto. (The House bill did not pass with a veto-proof margin.)

H.R.810 specifies that 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.

At the same time, the House debated and passed H.R.2520, the “Stem Cell Research and Therapeutic Act.” This legislation, which passed the House with only one dissenting vote, would require contracts with cord blood stem cell banks to assist in collecting and maintaining human cord blood for transplantation. Proponents of this bill, authored by Rep. Chris Smith (R-NJ) and others, offered it as an alternative to H.R.810. They argued that there is considerable scientific evidence of the medical benefit of cord blood stem cells, while no such evidence exists for embryonic stem cells. They argued as well that the development of cell lines from cord blood does not result in the destruction of embryos. The legislation also reauthorizes the National Bone Marrow Registry.

Return to top

Senate Committee Reports Rx Drug Monitoring Legislation

On May 25, the Senate Committee on Health, Education, Labor & Pensions (HELP) reported S.518, the “National All Schedules Prescription Electronic Reporting Act,” sponsored by Sen. Jeff Sessions (R-AL) and others.

The bill would require the Secretary of HHS to award state grants to establish or improve controlled substances monitoring programs. This would include a state establishing an electronic database with reports from dispensers of prescriptions for controlled substances. Information from these databases could be provided, on request, to law enforcement and narcotics control authorities, federal agencies, and others. The Secretary, in awarding the funds, would establish a uniform electronic format. Funds would be awarded to states generally according to a formula based on the number of pharmacies in the state as compared with the number of pharmacies nationwide. The bill would authorize $25 million for each of FY 2006 and 2007 and $15 million for each of the subsequent three years.

The driving force behind this legislation, like similar legislation introduced in the House (H.R.1132 and H.R.1139) is the alarming increase in diversion and abuse of prescription drugs, including oxycontin. This type of legislation has been supported strongly by Rep. Harold Rogers (R-KY), who was instrumental in establishing and funding an electronic Rx monitoring program in Kentucky. In speaking of this program, Rogers credits it with reversing a situation in his state he describes as disastrous, with multiple deaths resulting from misuse and abuse of oxycontin.

Significant technical and philosophical differences exist between the House bills and the House and Senate bills that could be hurdles to reaching a consensus and moving this kind of legislation to the President’s desk. Although the House Energy & Commerce Committee has held hearings on the issue, no action has been taken. It also is unclear how quickly the HELP Committee-approved bill will move to the Senate floor.

Return to top

House Committees Take Up Pro Sports Steroid Legislation

On May 25, the House Energy & Commerce Subcommittee on Commerce, Trade, & Consumer Protection reported the “Drug Free Sports Act,” H.R.1862. Introduced by Rep. Cliff Stearns (R-FL), the bill would require the Secretary of Commerce to promulgate regulations requiring professional sports organizations to establish, maintain, and enforce independent party drug testing of athletes according to minimum standards. The substances to be tested for, generally steroids, are defined as those prohibited by the World Anti-Doping Agency and determined by the Secretary of Commerce, in consultation with FDA, to be performance-enhancing substances.

The bill would allow exemptions for certain uses of prohibited substances for legitimate medical purposes, and would require strong penalties – a two year suspension for a first violation and a lifetime ban from the sport for a second. The bill would establish substantial monetary penalties for any sports association that does not implement these requirements. Reports to Congress are also required from both the Secretary of Commerce, regarding the effectiveness of this testing, and from the GAO, regarding testing of high school and college athletes. The Subcommittee unanimously ordered the bill reported to the full Committee, which is expected to take it up shortly after the congressional Memorial Day work period.

On May 26, the House Government Reform Committee unanimously ordered reported H.R.2565, the “Clean Sports Act,” which also addresses steroid use by professional athletes. H.R.2565, co-sponsored by Reps. Tom Davis (R-VA) and Henry Waxman (R-CA), a companion to Sen. John McCain’s (R-AZ) S.1114, would make it unlawful for a professional sports organization to organize, produce, or promote a game without putting into place drug testing programs as strict as those of the U.S. Anti-Doping Agency.

The Clean Sports Act lays out minimum standards, such as testing at least five times per year, and penalties similar to those of H.R.1862. It would authorize the Director of the Office of National Drug Control Policy to modify the requirements laid out in the bill. Violation of these requirements would fall under section 18 of the Federal Trade Commission (FTC) Act regarding unfair or deceptive acts or practices. The FTC would be authorized to enforce these provisions, including authority for increased monetary penalties as compared with those generally levied for such violations.

Although significant differences exist between the two bills with regard to the mechanisms of regulation and enforcement, virtually no differences exist in the thrusts of the bills – to force professional sports organizations to strengthen and enforce drug testing programs. Quick House action on the issue is likely, based on the expeditious and forceful Committee action in both cases, following on the heels of both Committees having highly visible hearings on the topic.

 

Return to top

House Appropriations Committee Approves Ag Spending After Contentious Debate

On Wednesday, the House Appropriations Committee approved a $100 billion spending bill for FDA, USDA and related agencies - $93 million more than Bush requested. However, the real fireworks surrounded two failed FDA proposals.

Rep. Maurice Hinchey (D-NY) introduced an amendment that would have allowed FDA to require studies once drugs are on the market if the agency believes that either a drug or drug class may be too dangerous based on data from a range of organizations or “other sources as the secretary determines to be appropriate.” The amendment also called for allowing FDA to require label changes if FDA determines a label fails to provide adequate safety or efficacy information.

Many Republican members apposed the amendment because it was creating “authorizing” language on a spending bill. Yet Hinchey and ranking member David Obey (D-WI) countered that authorizing provisions are often offered, and passed, by Republican members. The amendment failed 31-to-25.

A separate amendment by Rep. Jack Kingston (R-GA) on “Drug Efficacy Study Implementation” drugs (DESI drugs) also failed by a voice vote. Kingston’s amendment would have restricted FDA from withdrawing drugs that were on the market before efficacy requirements were enacted in 1962.

 

Return to top


“Full Funding” to Implement DSHEA Introduced

On May 19, Reps. Dan Burton (R-IN) and Frank Pallone (D-NJ) introduced H.R.2485, the “Dietary Supplement Health and Education Act (DSHEA) Full Implementation and Enforcement Act.” The bill would authorize $20, 30, 40, 50, and 65 million for each of FY2006-2010 for FDA and $30 million for FY2006 and “such sums as necessary” for the subsequent four fiscal years, to implement DSHEA provisions.

Among the bills Findings are that more than 158 million consumers spend more than $17 billion annually to purchase dietary supplement products, that DSHEA provided FDA with authority to set standards for good manufacturing of supplements and to remove unsafe products from the market, and that FDA has not adequately exercised this authority. The Findings acknowledge that one of the reasons for FDA’s lack of activity is that the agency has had insufficient resources; the bill is intended to remedy that problem.

On the same day, Pallone introduced H.R.2510, which is identical with H.R.2485 in provisions relating to the authorization of funds, but includes several additional items. H.R.2485 requires the Secretary of Health and Human Services through the FDA to establish a system for the reporting of adverse events related to the use of dietary supplements; authorizes appropriations for programs to educate consumers and health care providers about the benefits and safety of supplements, and requires a detailed annual report to Congress (beginning January 2007) on the implementation and enforcement of DSHEA.

Finally, the bill includes a Sense of Congress that, if the Secretary finds that a supplement containing ephedrine alkaloids presents a significant or unreasonable risk of illness or injury, all supplements with those ingredients should be taken off the market. A second Sense of the Congress urges the Secretary to ensure that botanical sources of ephedrine alkaloids should remain available if they have not been chemically altered or manipulated, are marketed at dosage levels used in traditional herbal formulas, and are labeled only for traditional uses (not for weight loss or energy).

 

Return to top

Congress Responds to Medicaid Coverage of ED Drugs

Responding to reports that Medicaid had paid, in several states, for erectile dysfunction (ED) drugs for released or paroled criminals who had been convicted of sex crimes, Sen. Chuck Grassley (R-IA) and three cosponsors introduced S.1113 on May 24 and Sens. Chuck Schumer (D-NY) and Hillary Clinton (D-NY) introduced S.1126 on May 25. The bills prohibit the expenditure of federal funds to pay for ED drugs. S.1113 prohibits payment or reimbursement for any patient, including individuals convicted of crimes relating to sexual abuse, assault, etc., while the Schumer-Clinton bill applies only to convicted criminals. Both bills would prohibit payment or reimbursement in any federal program, including Medicaid, VA, Department of Defense, Indian Health Service, Public Health Service, and the Federal Employees’ Health Benefits insurance. On May 26, Rep. Vito Fossella (R-NY) and eight cosponsors introduced H.R.2648, to require Medicaid drug utilization review programs to deny coverage of ED drugs for sex offenders.

The Centers for Medicare and Medicaid Services already had taken steps following these reports, stating that Medicaid payment for such drugs for convicted criminals represented an “oversight” in state Medicaid payment policies. On May 23, CMS Medicaid Director Dennis Smith wrote to all state Medicaid Directors to “remind states that there a number of options to prevent the inappropriate use of such drugs and to inform states that we believe they should restrict the coverage of such drugs in the case of individuals convicted of a sex offense.” The letter instructs states immediately to “use their drug use review programs and procedures under 1927(g) of the Social Security Act and work with physicians and pharmacists to prevent inappropriate Medicaid payment …”

 

Return to top

FDA Reports Progress Against Counterfeit Drugs

In an annual update issued May 18 to its report “Combating Counterfeit Drugs,” FDA indicated it has made substantial progress in controlling market availability of counterfeit prescription drugs. The report summarizes action taken by the agency, particularly through its Office of Criminal Investigations, which undertook 58 counterfeit drug investigations in the year 2004, as compared with 30 in 2003.

Even as they pursued more cases, however, investigators determined that most quantities of counterfeit drugs were smaller than had been seen previously. The agency also has taken steps, the report says, to improve coordination with other federal agencies, as well as state and foreign law enforcement.

In addition, the update reports progress in the development and implementation of Electronic Product Code (EPC) and Radio-Frequency Identification (RFID) as tools to provide an accurate pedigree for drugs moving through the commercial supply chain. The report states that three drug manufacturers plan to incorporate RFID technology into at least one product by the end of this year and a number of distributors have initiated pilot programs for tagging products considered to be at risk of counterfeiting.

The update acknowledges that technical issues remain to be resolved before RFID or related technology can be incorporated and used routinely, including questions about the effects of RFID on drug products. In particular, there are questions about the effects on biological/protein-based products, which could be susceptible to change from this. FDA is working with the Product Quality Research Institute (PQRI) on these questions and with its own laboratory in the Center for Devices and Radiological Health. Meanwhile, drug companies are using other kinds of tracking and anti-counterfeit technologies such as holography and color shifting ink.

FDA also points to a number of activities it has undertaken to inform and educate the public about risks from counterfeit drugs, including establishing the website www.fda.gov/counterfeit, public service announcements, working with consumer groups to disseminate information in the form of written materials, and encouraging physicians (and consumers) to report potential counterfeit products via MedWatch.

Notwithstanding the reported progress and the ongoing commitment, FDA says, “there remains a viable and concrete threat of counterfeit drugs entering the U.S. drug distribution system.”

Return to top

FDA Publishes Draft Guidance on “Useful Consumer Information”

In the May 25 Federal Register, FDA published a draft guidance, “Useful Written Consumer Medication Information (CMI).” The guidance is directed to individuals or organizations writing consumer information, but who are not the manufacturer of a drug product. Since neither the manufacturer nor the FDA would have any approval of, or veto over, such information, the guidance recommends some steps these organizations should take to make sure the information they provide to consumers is accurate and useful.

FDA notes in the background to the guidance that the law prevents the agency from regulating the content of consumer information, unless specific goals and timeframes could not be met by voluntary actions. Among other steps to evaluate the extent consumers were receiving useful information, the National Association of Boards of Pharmacy conducted a study in 2001 for FDA’s Advisory Committee on Drug Safety and Risk Management. The results indicated that while 89% of consumers were receiving some written information with their prescriptions, on average, the information was useful only about 50% of the time. The Advisory Committee recommended FDA take a more active role in the matter. The draft guidance is a response to that recommendation. The bottom-line goal is for 95% of consumer to receive useful information with their prescriptions by 2006.

Among the recommendations of the guidance is that information be scientifically accurate, unbiased, understandable and legible, timely, useful, and sufficiently specific and comprehensive. The guidance includes recommendations for content and format; how to communicate contraindications, directions for use, specific warnings, special storage conditions, etc. in the most user-friendly way; how to present the name of the product most comprehensively and usefully; and how to communicate instructions for patient response to adverse reactions. The guidance recommends specifically that information be provided in the order: personalized information in a box, established and brand names, purpose/use of the medication, warnings, instructions for use, side effects, and additional general information.

Comments are due on the draft guidance in 60 days.


Return to top

National Science Advisory Board for Biosecurity Meeting Scheduled

The inaugural meeting of the Department of Health and Human Services National Science Advisory Board for Biosecurity (NSABB) will be June 30-July 1, 2005. NSABB was established to provide advice, guidance and leadership regarding federal oversight of usual-use research, defined as biological research with legitimate scientific purposes that could be misused to pose a biological threat to public health and/or national security.

The agenda for the meeting includes a presentation and discussions on criteria for defining dual-use research in the life sciences and the role of a code of conduct for the life sciences; discussion of issues raised by dual-use research with respect to scientific communication, genome synthesis, and international perspectives; and public comments.

Any member of the public interested in presenting oral comments at the meeting may notify NSABB at least 10 days in advance of the meeting. Interested individuals and representatives of an organization may submit a letter of intent, a brief description of the organization represented and a short description of the oral presentation. Written comments will also be accepted until June 17, 2005.

Further information on the meeting is available at http://www.biosecurityboard.gov.

 

Return to top

OIE Shifts BSE Risk Recommendations, Rewrites Recommendations

The World Animal Health Organization (OIE) in Paris this week completed its rewrite and approval of its chapter on BSE risk and national categorization. The focus of the meeting addressed three proposals: A recommendation to add deboned skeletal meats and blood/blood products to the list of “tradable" or exempt (non-risk) commodities; a shift in the national categorization system from five categories to three and a change in the surveillance criteria by which a nation would achieve categorization.

Dr. Peter Fernandez, deputy administrator of USDA’s Animal & Plant Health Inspection Service (APHIS) and president of the U.S. OIE region, reported heavy Asian nation opposition to the changes, particularly from Japan, Korea, Singapore and Taipei. Some South American nations registered minor concerns.

The U.S. favors the OIE changes, a stance the U.S. has held and pushed within OIE. When Asian delegates tried to place several stipulations on meat trade, the U.S. asked: if OIE says meat is safe, what will the world think about restrictions on its trade? Further, the U.S. argued the recommendations were the result of consensus among world scientific experts and questioned if the political delegates to OIE to should challenge that consensus.

After two days of debate, the following changes were approved:

• Muscle meats are added to the list of tradable commodities under the following conditions: shipments must be from animals under 30 months of age and must be accompanied by a veterinary certificate showing the product did not come from an animal with BSE; there must be ante and post-mortem inspection; no mechanically deboned product is allowed and the animals can’t have been stunned using gas/air, pithing or similar stunning methods. Blood and blood products were accepted as non-risk, tradable commodities. Meat from animals over 30 months of age will trade under current standards. There will be a push next year to remove the under-30-month provision.

• Under new categories of risk, the number of categories drops from five to three -- "negligible risk", "controlled risk" and "undetermined risk." Countries now classified as free or provisionally free nations (Argentina, Uruguay, Paraguay and Singapore) will resubmit dossiers for a new classification. Other nations must now reapply for a new category designation. USDA officials stressed the U.S. will now consider its options in light of what other countries do and the dossiers submitted. Any nation that has a submission in the OIE pipeline today will be classified under the 2004 standards and would resubmit in one year for a new category designation.

• The surveillance criteria were changed so that to achieve 0 cases with 95% confidence of no BSE, a nation must operate under a 1/100,000 surveillance level; maintenance level would be 1/50,000 animals.

Return to top

One More Baby Step By Japan on Beef Trade

Asking the fundamental question, “Is U.S. beef as safe as Japanese beef?” the Japanese government this week asked food regulators to study the feasibility of at least partially lifting the current ban on U.S. beef imports. The Food Safety Commission earlier this month recommended the government waive cattle testing on animals less than 21 months of age.

Japan has 18 confirmed cases of BSE. The U.S. has detected one case of BSE, in a cow imported from Canada.

Return to top

Conferees Named to Highway Reauthorization Bill

House and Senate leadership named conferees to begin reconciling the respective chambers' version of federal highway program reauthorization, with the highest hurdle to overcome being the legislation’s price tag. As evidence of that fact, the first meetings of the conferees won’t take place until the first or second week in June – after Republican leaders meet with the White House to get marching orders. The White House has threatened to veto a highway bill costing more than the $283 billion deemed adequate by the President; the Senate’s bill costs out at nearly $295 billion.

Meanwhile, Congress approved its seventh extension of the existing highway programs just before it left for its Memorial Day recess.

The Senate bill contains language making permanent the hours of service exemption for agriculture, valid within a 100-mile radius of the source of commodities or distribution of farm supplies in each state. There is also language allowing for the spending of federal dollars to control invasive species and for revegetation efforts.

Return to top

Senate Committee Approves Comprehensive Energy Package; Showdown Set on Senate Floor and With House Version

Having handled as many issues as it could without bogging down, the Senate Energy & Natural Resources Committee this week completed its markup of comprehensive energy legislation, opting to leave contentious issues for the Senate floor debate and conference with the House.

Of significant importance to agriculture is committee approval of an amendment to increase the amount of alternative fuels – ethanol and biodiesel – mandated in the Renewable Fuels Standard (RFS) for blending by diesel refiners. While the House bill carries a 6-billion-gallon mandate, the Senate committee approved a mandate of 8 billion gallons by 2012, doubling the amount of alternative fuel production in the U.S.

Sen. Jim Inhofe (R-OK), chair of the Senate Environment & Public Works Committee, urged the committee not to include the RFS amendment, fearing it would jeopardize the bill on the floor. He cited a report by the Energy Information Administration that estimates an 8-billion-gallon RFS would increase the cost of gasoline by 2.4 cents per gallon. The American Petroleum Institute, which represents refiners, said it was “disappointed” in the committee’s action and predicted higher energy costs.

It’s expected Inhofe will prevail on the Senate floor, even though groups such as the American Farm Bureau Federation and other ag organizations support the higher RFS standard. If unsuccessful in the Senate, the House has already signaled its unwillingness to go along with the higher standard, with a final level at around 6 billion gallons.

Return to top

Irish Authorities Seize U.S. Shipment of Corn Gluten Feed With Bt-10;
EE Continues Deadlock Over Biotech Corn Imports

In the up and down saga of Syngenta’s unapproved biotech corn seed finding its way into corn and corn products, the Irish government this week seized a U.S. shipment of corn gluten feed because it contained the unapproved variety of Bt-10. The shipment was the first to test positive since the European Union (EU) began requiring certification and testing of U.S. corn and corn product imports in April.

Meanwhile, EU ministers failed for the 11th and 12th time to reach accord on applications to import biotech corn into Europe. The ministers voted 8-9, with 8 abstentions, failing to approve an application for corn-borer-resistant corn for feed use by Pioneer Hi-Bred and Dow AgroSciences/Mycogen Seed. A second application for Monsanto’s rootworm-resistant corn for import for use as an ingredient in processed food was deadlocked on a 10-8 vote with 6 abstentions.

Return to top

CAFTA Battle Heating Up

President Bush is targeting high-profile congressional Democrats in his battle to win approval for CAFTA, but major deal cutting will have to happen before the treaty gets a floor vote in either chamber. In addition, Secretary of State Condoleezza Rice and Secretary of Defense Donald Rumsfeld have been meeting with targeted members of Congress press the security issues included in the treaty.

Specific issues dividing the House and Senate on CAFTA are sugar imports and labor protections. General ambivalence about the treaty centers on statistics showing the U.S. is already the biggest market for most CAFTA-nation exports and market potential for U.S. products is relatively low.

The White House push starts with Senate Finance Committee Democrats – the committee expects to hold a mock mark-up on the treaty June 13 – and includes invitations to Sens. Max Baucus (D-MT), Jeff Bingaman (D-NM), Blanche Lincoln (D-AR) and Ron Wyden (D-OR) to meet with Bush. The strategy here is to get Democrat leaders to come to the pro-CAFTA camp, thereby pulling moderate Democrats from the anti or undecided sides of the issue. Finance Committee Chair Chuck Grassley (R- IA), along with undecided committee members Sens. Ben Nelson (D-NE), Olympia Snowe (R-ME) and Craig Thomas (R-WY), have also been invited to the meeting.

At the same time, other high-profile Democrats, including several former members of Congress, are being enlisted to push the CAFTA cause. Former Rep. Cal Dooley (D-CA), now president of the Food Processors Assn., and former House member and Secretary of Agriculture Dan Glickman, now president of the Motion Picture Association of America, were at a meeting this week with Hill types and Ambassador Rob Portman, U.S. Special Trade Representative.

Return to top

Grain Standards Act Gets Review in House, Senate

A House Agriculture Committee subcommittee and the full Senate Agriculture Committee this week held hearings as they begin their reauthorization of the U.S. Grain Standards Act. The Administration is asking the act be reauthorized through 2015. The committees are reviewing several sections of the Act set to expire, including authority to collect fees to cover administrative and supervisory activities on grain inspections; authority to collect fees to perform official inspections, official weighing or supervision of weighing grain; the authority to receive appropriations; the 30% cap on administrative and supervisory costs and the authority for the USDA Grain Inspection Advisory Committee.

Return to top

EPA Wants Applications on Methyl Bromide Exemptions For Critical Use

The Environmental Protection Agency (EPA) is asking for applications for a “critical use exemption” from the phase-out of methyl bromide for 2007 and beyond. Users of methyl bromide have the opportunity to provide technical and economic information to support a critical use claim. At the same time, EPA wants to hear about the technical and economic feasibility of methyl bromide alternatives. Details of the application process can be found in the May 23, 2005, Federal Register, accessed at http://www.access.gpo.gov/.

Once the exemption applications are received, EPA will submit the data for national U.S. nomination for review of the countries signed on to the Montreal Protocol, which must approve critical use exemptions.

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.1118
Sen. Russ Feingold (D-WI) introduced a bill to reduce irrigation subsidies.

S.1126
A bill proposed by Sens. Charles Schumer (D-NY) and Hillary Clinton (D-NY) would prohibit Federal funds from being expended for the payment or reimbursement of a drug that is prescribed to a sex offender for the treatment of sexual or erectile dysfunction.

S.1128
Sen. Ron Wyden (D-OR) offered a bill to provide for increased rebates under the Medicaid program for prescription drugs that are directly advertised to consumers, and to require other Federal programs purchasing or reimbursing for such drugs to establish payment and reimbursement mechanisms that reduce the costs of those drugs.

H.R.2541
Rep. Peter King (R-IA) introduced a bill to provide for the expansion, intensification, and coordination of NIH activities regarding qualifying adult stem cell research.

H.R.2562
A bill introduced by Rep. Sherrod Brown (D-OH) aims to preserve the effectiveness of antibiotics used in the treatment of human and animal diseases.

H.R.2565
Rep. Tom Davis (R-VA) proposed legislation to establish minimum drug testing standards for major professional sports leagues.

H.R.2574
Rep. Roscoe Bartlett (R-MD) proposed a bill to provide for a NIH program that would conduct and support research on animals to develop techniques for the derivation of stem cells from embryos preserve the embryos.

H.R.2600
Legislation offered by Rep. Clay Shaw, Jr. (R-FL) amends the Federal Food, Drug, and Cosmetic Act with respect to the sale or trade of prescription drugs that were knowingly caused to be adulterated or misbranded.

H.R.2626
Rep Chet Edwards (D-TX) introduced a bill to prohibit Medicare and Medicaid coverage of sex-enhancing drugs for individuals convicted of a sex offense.

H.R.2648
Rep. Vito Fossella (R-NY) proposed a bill to prohibit Medicaid from providing coverage of erectile dysfunction drugs for individuals registered as sex offenders.

H.R.2657
A bill offered by Rep. Brian Baird (D-WA) would provide medical malpractice reform.

H.R.2685
Rep. John Larson (D-CT) introduced legislation to provide for prescription drugs at reduced prices to Medicare beneficiaries.

Return to top

 

Inside Track is produced as a service to clients of Policy Directions, Inc., a Washington, DC-based government relations/strategic government communications firm founded in 1995, specializing in customized advocacy on health care; food; biomedical research; biotechnology, human drug, and medical device regulation; federal nutrition policy and programs; and environmental policies and programs. For more information about PDI, please e-mail info@poldir.com.

All material © 2005 Policy Directions.

Policy Directions Inc | 818 Connecticut Ave NW Suite 950 | Washington, DC 20006 | (202) 776-0071 | info@poldir.com