Debbie Stabenow on Health Care Democratic Jr Senator; previously Representative (MI-8)

Health coverage needs to be a right, not a privilege

STABENOW: Healthcare coverage needs to be a right, not a privilege. I’ve been laser focused on working with auto industry to more adequately and effectively to lower costs of prescription drugs. I’ve worked bi-partisan to allow you to bring prescription drugs back from Canada legally.

BOUCHARD: I do not support universal healthcare that the government. But we can and should do many things - such as tort reform.

Busload of seniors to Canada to buy Rx drugs at half price

Pledged to lower prescription drug prices for seniors

"This legislation is a commonsense approach to solving one of the most pressing problems facing our entire health care system" she says. "It's simply unconscionable that consumers are prevented from shopping around for the best possible price for their prescription medications."

Voted NO on the Ryan Budget: Medicare choice, tax & spending cuts.

[Sen. DeMint, R-SC]: The Democrats have Medicare on a course of bankruptcy. Republicans are trying to save Medicare & make sure there are options for seniors in the future. Medicare will not be there 5 or 10 years from now. Doctors will not see Medicare patients at the rate [Congress will] pay.

[Sen. Ayotte, R-NH]: We have 3 choices when it comes to addressing rising health care costs in Medicare. We can do nothing & watch the program go bankrupt in 2024. We can go forward with the President's proposal to ration care through an unelected board of 15 bureaucrats. Or we can show real leadership & strengthen the program to make it solvent for current beneficiaries, and allow future beneficiaries to make choices.

Opponent's Arguments for voting No:

[Sen. Conrad, D-ND]: In the House Republican budget plan, the first thing they do is cut $4 trillion in revenue over the next 10 years. For the wealthiest among us, they give them an additional $1 trillion in tax reductions. To offset these massive new tax cuts, they have decided to shred the social safety net. They have decided to shred Medicare. They have decided to shred program after program so they can give more tax cuts to those who are the wealthiest among us.

[Sen. Merkley, D-TK]: The Republicans chose to end Medicare as we know it. The Republican plan reopens the doughnut hole. That is the hole into which seniors fall when, after they have some assistance with the first drugs they need, they get no assistance until they reach a catastrophic level. It is in that hole that seniors have had their finances devastated. We fixed it. Republicans want to unfix it and throw seniors back into the abyss. Then, instead of guaranteeing Medicare coverage for a fixed set of benefits for every senior--as Medicare does now--the Republican plan gives seniors a coupon and says: Good luck. Go buy your insurance. If the insurance goes up, too bad.
Status: Failed 40-57

Voted YES on regulating tobacco as a drug.

Opponent's argument to vote No:Rep. HEATH SHULER (D, NC-11): Putting a dangerous, overworked FDA in charge of tobacco is a threat to public safety. Last year, the FDA commissioner testified that he had serious concerns that this bill could undermine the public health role of the FDA. And the FDA Science Board said the FDA's inability to keep up with scientific advancements means that Americans' lives will be at risk.

Proponent's argument to vote Yes: Rep. HENRY WAXMAN (D, CA-30): The bill before us, the Waxman-Platts bill, has been carefully crafted over more than a decade, in close consultation with the public health community. It's been endorsed by over 1,000 different public health, scientific, medical, faith, and community organizations.

Sen. HARRY REID (D, NV): Yesterday, 3,500 children who had never smoked before tried their first cigarette. For some, it will also be their last cigarette but certainly not all. If you think 3,500 is a scary number, how about 3.5 million. That is a pretty scary number. That is how many American high school kids smoke--3.5 million. Nearly all of them aren't old enough to buy cigarettes. It means we have as many boys and girls smoking as are participating in athletics in high schools. We have as many as are playing football, basketball, track and field, and baseball combined.

Voted YES on expanding the Children's Health Insurance Program.

• Reauthorizes State Children's Health Insurance Program (SCHIP) through FY2013 at increased levels.
• Gives states the option to cover targeted low-income pregnant women
• Phases out coverage for nonpregnant childless adults.

Rep. FRANK PALLONE (D, NJ-6): In the last Congress, we passed legislation that enjoyed bipartisan support as well as the support of the American people. Unfortunately, it did not enjoy the support of the President, who vetoed our bill twice, and went on to proclaim that uninsured children can simply go to the emergency room to have their medical needs met. As the Nation moves deeper into a recession and unemployment rates continue to rise, millions of Americans are joining the ranks of the uninsured, many of whom are children. We can't delay. We must enact this legislation now.

Opponent's argument to vote No:Rep. ROY BLUNT (R, MI-7): This bill doesn't require the States to meet any kind of threshold standard that would ensure that States were doing everything they could to find kids who needed insurance before they begin to spend money to find kids who may not have the same need. Under the bill several thousands of American families would be poor enough to qualify for SCHIP and have the government pay for their health care, but they'd be rich enough to still be required to pay the alternative minimum tax. The bill changes welfare participation laws by eliminating the 5-year waiting period for legal immigrants to lawfully reside in the country before they can participate in this program. In the final bill, we assume that 65% of the children receiving the benefit wouldn't get the benefit anymore. It seems to me this bill needs more work, would have benefited from a committee hearing. It doesn't prioritize poor kids to ensure that they get health care first.

Voted YES on overriding veto on expansion of Medicare.

• Extends Medicare to cover additional preventive services.
• Includes body mass index and end-of-life planning among initial preventive physical examinations.
• Eliminates by 2014 [the currently higher] copayment rates for Medicare psychiatric services.

I support the primary objective of this legislation, to forestall reductions in physician payments. Yet taking choices away from seniors to pay physicians is wrong. This bill is objectionable, and I am vetoing it because:
• It would harm beneficiaries by taking private health plan options away from them.
• It would undermine the Medicare prescription drug program.
• It is fiscally irresponsible, and it would imperil the long-term fiscal soundness of Medicare by using short-term budget gimmicks that do not solve the problem.

Proponent's argument to vote Yes: Sen. PATTY MURRAY (D, WA): President Bush vetoed a bill that would make vital improvements to the program that has helped ensure that millions of seniors and the disabled can get the care they need. This bill puts an emphasis on preventive care that will help our seniors stay healthy, and it will help to keep costs down by enabling those patients to get care before they get seriously ill. This bill will improve coverage for low-income seniors who need expert help to afford basic care. It will help make sure our seniors get mental health care.

Voted NO on means-testing to determine Medicare Part D premium.

SUPPORTER'S ARGUMENT FOR VOTING YES: Sen. ENSIGN: This amendment is to means test Medicare Part D the same way we means test Medicare Part B. An individual senior making over $82,000 a year, or a senior couple making over $164,000, would be expected to pay a little over $10 a month extra. That is all we are doing. This amendment saves a couple billion dollars over the next 5 years. It is very reasonable. There is nothing else in this budget that does anything on entitlement reform, and we all know entitlements are heading for a train wreck in this country. We ought to at least do this little bit for our children for deficit reduction.

OPPONENT'S ARGUMENT FOR VOTING NO: Sen. BAUCUS: The problem with this amendment is exactly what the sponsor said: It is exactly like Part B. Medicare Part B is a premium that is paid with respect to doctors' examinations and Medicare reimbursement. Part D is the drug benefit. Part D premiums vary significantly nationwide according to geography and according to the plans offered. It is nothing like Part B.

Second, any change in Part D is required to be in any Medicare bill if it comes up. We may want to make other Medicare changes. We don't want to be restricted to means testing.

Third, this should be considered broad health care reform, at least Medicare reform, and not be isolated in this case. LEGISLATIVE OUTCOME:Amendment rejected, 42-56

Voted NO on allowing tribal Indians to opt out of federal healthcare.

TRIBAL MEMBER CHOICE PROGRAM: Members of federally-recognized Indian Tribes shall be provided the opportunity to voluntarily enroll, with a risk-adjusted subsidy for the purchase of qualified health insurance in order to--
1. improve Indian access to high quality health care services;
2. provide incentives to Indian patients to seek preventive health care services;
3. create opportunities for Indians to participate in the health care decision process;
4. encourage effective use of health care services by Indians; and
5. allow Indians to make health care coverage & delivery decisions & choices.

SUPPORTER'S ARGUMENT FOR VOTING YES:Sen. COBURN: The underlying legislation, S.1200, does not fix the underlying problems with tribal healthcare. It does not fix rationing. It does not fix waiting lines. It does not fix the inferior quality that is being applied to a lot of Native Americans and Alaskans in this country. It does not fix any of those problems. In fact, it authorizes more services without making sure the money is there to follow it.

Those who say a failure to reauthorize the Indian Health Care Improvement Act is a violation of our trust obligations are correct. However, I believe simply reauthorizing this system with minor modifications is an even greater violation of that commitment.

OPPONENT'S ARGUMENT FOR VOTING NO:Sen. DORGAN: It is not more money necessarily that is only going to solve the problem. But I guarantee you that less money will not solve the problem. If you add another program for other Indians who can go somewhere else and be able to present a card, they have now taken money out of the system and purchased their own insurance--then those who live on the reservation with the current Indian Health Service clinic there has less money. How does that work to help the folks who are stranded with no competition?

LEGISLATIVE OUTCOME:Amendment rejected, 28-67

Voted YES on adding 2 to 4 million children to SCHIP eligibility.

Proponents support voting YES because:

Rep. DINGELL: This is not a perfect bill, but it is an excellent bipartisan compromise. The bill provides health coverage for 3.9 million children who are eligible, yet remain uninsured. It meets the concerns expressed in the President's veto message [from HR976]:

1. It terminates the coverage of childless adults.
2. It targets bonus payments only to States that increase enrollments of the poorest uninsured children, and it prohibits States from covering families with incomes above $51,000.
3. It contains adequate enforcement to ensure that only US citizens are covered.

Opponents recommend voting NO because:

Rep. DEAL: This bill [fails to] fix the previous legislation that has been vetoed:

• On illegal immigration: Would the verification system prevent an illegal alien from fraudulently using another person's name to obtain SCHIP benefits? No.
• On adults in SCHIP: Up to 10% of the enrollees in SCHIP will be adults, not children, in the next 5 years, and money for poor children shouldn't go to cover adults.
• On crowd-out: The CBO still estimates there will be some 2 million people who will lose their private health insurance coverage and become enrolled in a government-run program.

Veto message from President Bush:

Like its predecessor, HR976, this bill does not put poor children first and it moves our country's health care system in the wrong direction. Ultimately, our goal should be to move children who have no health insurance to private coverage--not to move children who already have private health insurance to government coverage. As a result, I cannot sign this legislation.

Voted YES on requiring negotiated Rx prices for Medicare part D.

Proponents support voting YES because:

This legislation is an overdue step to improve part D drug benefits. The bipartisan bill is simple and straightforward. It removes the prohibition from negotiating discounts with pharmaceutical manufacturers, and requires the Secretary of Health & Human Services to negotiate. This legislation will deliver lower premiums to the seniors, lower prices at the pharmacy and savings for all taxpayers.

It is equally important to understand that this legislation does not do certain things. HR4 does not preclude private plans from getting additional discounts on medicines they offer seniors and people with disabilities. HR4 does not establish a national formulary. HR4 does not require price controls. HR4 does not hamstring research and development by pharmaceutical houses. HR4 does not require using the Department of Veterans Affairs' price schedule.

Opponents support voting NO because:

Does ideological purity trump sound public policy? It shouldn't, but, unfortunately, it appears that ideology would profoundly change the Medicare part D prescription drug program, a program that is working well, a program that has arrived on time and under budget. The changes are not being proposed because of any weakness or defect in the program, but because of ideological opposition to market-based prices. Since the inception of the part D program, America's seniors have had access to greater coverage at a lower cost than at any time under Medicare.

Under the guise of negotiation, this bill proposes to enact draconian price controls on pharmaceutical products. Competition has brought significant cost savings to the program. The current system trusts the marketplace, with some guidance, to be the most efficient arbiter of distribution.
Status: Cloture rejected Cloture vote rejected, 55-42 (3/5ths required)

Voted NO on limiting medical liability lawsuits to $250,000.

Proponents of the motion recommend voting YEA because:
• Many doctors have had to either stop practicing medicine due to increased insurance premiums.
• Patients are affected as well--due to rising malpractice rates, more and more patients are not able to find the medical specialists they need.
• The cost of medical malpractice insurance premiums are having wide-ranging effects. It is a national problem, and it is time for a national solution.
• I am pleased that S. 22 extends liability protections to all health care providers and institutions.
• These bills are a commonsense solution to a serious problem, and it is time for us to vote up or down on this legislation.

Opponents of the motion recommend voting NAY because:
• We have virtually no evidence that caps on economic damages will actually lower insurance rates. And in my view, these caps are not fair to victims.
• If we want to reduce malpractice insurance premiums we must address these problems as well as looking closely at the business practices of the insurance companies. What we shouldn't do is limit the recovery of victims of horrible injury to an arbitrarily low sum.
• This is obviously a complicated issue. This is the kind of issue that needs to be explored in depth in our committees so that a consensus can emerge. So I will vote no on cloture, and I hope that these bills will go through committees before we begin floor consideration of this important topic.

Voted YES on expanding enrollment period for Medicare Part D.

Voted YES on increasing Medicaid rebate for producing generics.

Voted YES on negotiating bulk purchases for Medicare prescription drug.

Voted YES on $40 billion per year for limited Medicare prescription drug benefit.

Voted YES on allowing reimportation of Rx drugs from Canada.

Voted YES on allowing patients to sue HMOs & collect punitive damages.

Voted NO on funding GOP version of Medicare prescription drug benefit.

Voted NO on subsidizing private insurance for Medicare Rx drug coverage.

Voted NO on banning physician-assisted suicide.

Voted NO on establishing tax-exempt Medical Savings Accounts.

Establish "report cards" on HMO quality of care.

Promote Universal Access and Quality in Health Care
That more than 40 million Americans lack health insurance is one of our society’s most glaring inequities. Lack of insurance jeopardizes the health of disadvantaged Americans and also imposes high costs on everyone else when the uninsured lack preventive care and get treatment from emergency rooms. Washington provides a tax subsidy for insurance for Americans who get coverage from their employers but offers nothing to workers who don’t have job-based coverage.

Markets alone cannot assure universal access to health coverage. Government should enable all low-income families to buy health insurance. Individuals must take responsibility for insuring themselves and their families whether or not they qualify for public assistance.

Finally, to help promote higher quality in health care for all Americans, we need reliable information on the quality of health care delivered by health plans and providers; a “patient’s bill of rights” that ensures access to medically necessary care; and a system in which private health plans compete on the basis of quality as well as cost.

Goals for 2010
• Reduce the number of uninsured Americans by two-thirds through tax credits, purchasing pools, and other means.
• Create a system of reliable “report cards” on the quality of care delivered by health plans and providers.

Invest funds to alleviate the nursing shortage.

• Amends Medicare to provide for nurse education training payments to qualified entities.
• Amends Medicaid to temporarily increase the matching rate for Medicaid nurse aide training and competency evaluation programs.
• Amends the Internal Revenue Code to provide for the exclusion from gross income of amounts received under the National Nursing Service Corps Scholarship Program.
• Amends the Public Health Service Act to: (1) develop and issue public service announcements that advertise and promote the nursing profession, highlight the advantages and rewards of nursing, and encourage individuals from diverse communities and backgrounds to enter the nursing profession; and (2) award grants to designated eligible educational entities in order to increase the number of nurses.
• Establishes a National Nurse Service Corps Scholarship program that provides scholarships to individuals seeking nursing education in exchange for service by such individuals in areas with nursing shortages. Authorizes appropriations.

Let states make bulk Rx purchases, and other innovations.

To: The Honorable Tommy G. Thompson, Secretary, Department of Health & Human Services

Dear Secretary Thompson:

As you know, prescription drug costs have been surging at double-digit rates for the last six years. The average annual increase 1999 through 2003 was a massive 16%, seven times the rate of general inflation.

These increases fall hardest on senior citizens and the uninsured. Their health needs are often great, and their low incomes often make these products unaffordable. They have no ability to use their combined purchasing power to negotiate reasonable prices. Taxpayers pay tens of billions of dollars for the purchase of drugs by Medicaid—an expense that could be reduced significantly if states are permitted to negotiate for the best prices from drug manufacturers.

As you know, the Supreme Court has just ruled that Maine's innovative program to reduce prescription drug costs for the uninsured and senior citizens is not a violation of the Medicaid law. As a result of this decision, Maine can use the combined buying power of Medicaid and individuals purchasing drugs on their own to negotiate lower prices with drug manufacturers. Twenty-nine other states supported the position taken by Maine, and there is broad interest in many states in initiating similar programs.

The Supreme Court's ruling, however, left open the possibility that if the Department of Health and Human Services makes a finding that the Maine program violates the Medicaid statute, the Department's action would be upheld by the Court. We urge you not to intervene to block Maine's program or similar statutes in other states that achieve savings for taxpayers, the elderly, and the uninsured. Such programs must be carefully implemented to assure that the poor are not denied access to needed drugs, but there is no justification for the federal government to deny states the ability to negotiate lower drug prices on behalf of their neediest citizens.

Increase funding to combat the global HIV/AIDS epidemic.

S.AMDT.281 to S.CON.RES.23: To increase the budget allocation for programs to combat the global HIV/AIDS epidemic and to reduce the deficit.

Rated 100% by APHA, indicating a pro-public health record.

The American Public Health Association (APHA) is the oldest and largest organization of public health professionals in the world, representing more than 50,000 members from over 50 occupations of public health. APHA is concerned with a broad set of issues affecting personal and environmental health, including federal and state funding for health programs, pollution control, programs and policies related to chronic and infectious diseases, a smoke-free society, and professional education in public health.

The following ratings are based on the votes the organization considered most important; the numbers reflect the percentage of time the representative voted the organization's preferred position.

End government propaganda on Medicare bill.

Recently, the U.S. Department of Health and Human Services (HHS), through a public relations firm, distributed Video News Releases (VNRs) to numerous local television news stations across the country. These VNRs contain pre-scripted news story packages and B-Roll designed to influence local news station to run stories complimentary of the new Medicare law recently signed by President Bush. However, these VNRs may mislead many news stations because they do not identify that they are produced by the government. In addition, these materials are currently being evaluated to determine whether they are illegal "covert propaganda."

We urge you to immediately warn stations not to use these materials and pull any stories that use them.

These tapes can be identified as follows: Two English-language versions begin with B-Roll of video slides promoting the new Medicare law, followed by interview soundbites from Tommy Thompson, Secretary of the Department of Health and Human Services and Leslie Norwalk, Acting Deputy Administrator of the Centers for Medicare and Medicaid (CMS). Following these soundbites, a complete television news package is run, with a voice-over by a fictional reporter named "Karen Ryan." Following the news package, more B-Roll is provided, including scenes of President Bush's rally at the signing of the bill, scenes from a pharmacy and scenes of seniors playing table games.

It is critical to the credibility of an independent news media that covert government propaganda be rejected for use by news organizations. We also believe that honest government should not resort to such deceptive tactics, and it is our belief that these materials violate the above-mentioned Federal law. Thank you for your cooperation with this request.

Establish a national childhood cancer database.

Conquer Childhood Cancer Act of 2007 - A bill to advance medical research and treatments into pediatric cancers, ensure patients and families have access to the current treatments and information regarding pediatric cancers, establish a population-based national childhood cancer database, and promote public awareness of pediatric cancers.

Authorizes the Secretary to award grants to childhood cancer professional and direct service organizations for the expansion and widespread implementation of:
1. activities that provide information on treatment protocols to ensure early access to the best available therapies and clinical trials for pediatric cancers;
2. activities that provide available information on the late effects of pediatric cancer treatment to ensure access to necessary long-term medical and psychological care; and
3. direct resource services such as educational outreach for parents, information on school reentry and postsecondary education, and resource directories or referral services for financial assistance, psychological counseling, and other support services.

Sponsored merging Alzheimers diagnosis and care benefit.

Congressional Summary:The purpose of this Act is to increase diagnosis of Alzheimer's disease and related dementias, leading to better care and outcomes for Americans living with Alzheimer's disease and related dementias. Congress makes the following findings:

1. As many as half of the estimated 5.2 million Americans with Alzheimer's disease have never received a diagnosis.
2. An early and documented diagnosis and access to care planning services leads to better outcomes for individuals with Alzheimer's disease.
3. Combining the existing Medicare benefits of a diagnostic evaluation and care planning into a single package of services would help ensure that individuals receive an appropriate diagnosis as well as critical information about the disease and available care options.

Proponent's argument for bill: (The Alzheimer's Association, alz.org). The "Health Outcomes, Planning, and Education (HOPE) for Alzheimer's Act" (S.709/H.R. 1507) is one of the Alzheimer's Association's top federal priorities for the 113th Congress. The HOPE for Alzheimer's Act would improve diagnosis of Alzheimer's diseas

Keep ObamaCare's prevention, treatment, & recovery services.

Excerpts from Letter from 20 Senators to President Trump: Repealing the Affordable Care Act (ACA) with no clear plan for replacement will substantially worsen the opioid epidemic. Last year, Congress took important steps to address this national public health crisis, enacting two bipartisan laws to address the opioid epidemic and reform the way our health system treats mental health and substance use disorders.

The Comprehensive Addiction and Recovery Act improved access to substance use disorder prevention, treatment, and recovery services. It promoted the use of best practices when prescribing opioid pain-killers, strengthening state prescription drug monitoring programs, and expanding access to the life-saving drug naloxone.

The 21st Century Cures Act also included critical mental health and substance use disorder reforms, strengthening enforcement of mental health parity laws, promoting the integration of physical and mental health care. Most importantly, the 21st Century Cures Act dedicated $1 billion in new grant funding, which will be essential to helping states provide prevention, treatment, and recovery services to patients These bipartisan advances will be fundamentally undermined by repeal of the ACA.

Opposing argument: (Warren, D-MA, in StatNews.com, 11/28/2016): Senator Elizabeth Warren railed against the 21st Century Cures, saying the bill had been "hijacked" by the pharmaceutical industry. "I cannot vote for this bill,'' Warren said. "I will fight it because I know the difference between compromise and extortion." The current legislation includes $500 million for the FDA, well below the amount Democrats had sought. Warren and Washington Senator Patty Murray have long argued that they would only support Cures legislation that included significant investment in basic medical research. While Warren said she supported many of the provisions, she called others "huge giveaways" to the drug industry.

Keep healthcare mandate, according to CC survey.

The Christian Coalition Voter Guide inferred whether candidates agree or disagree with the statement, 'Repealing the Nationalized Health Care System that Forces Citizens to Buy Insurance ' Christian Coalition's self-description: "Christian Voter Guide is a clearing-house for traditional, pro-family voter guides. We do not create voter guides, nor do we interview or endorse candidates."

Preserve access to Medicaid & SCHIP during economic downturn.

A bill to preserve access to Medicaid and the State Children's Health Insurance Program during an economic downturn.

• Economic Recovery in Health Care Act of 2008 - Prohibits finalizing, implementing, enforcing, or otherwise taking any action, prior to April 1, 2009, on any changes to Medicaid programs or State Children's Health Insurance Program (SCHIP).
• Amends the U.S. Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007 to extend through April 1, 2009, the moratorium relating to the cost limit for providers.
• Amends the Medicare, Medicaid, and SCHIP Extension Act of 2007 to extend through April 1, 2009, the moratorium relating to rehabilitation services, school-based administration, and school-based transportation.
• Provides for state fiscal relief through a temporary increase of Medicaid federal medical assistance percentage (FMAP).

Expand the National Health Service Corps.

A bill to achieve access to comprehensive primary health care services for all Americans and to reform the organization of primary care delivery through an expansion of the Community Health Center and National Health Service Corps programs. Amends the Public Health Service Act to:
1. increase and extend the authorization of appropriations for community health centers and for the National Health Service Corps scholarship and loan repayment program for FY2010-FY2015, and provide for increased funding for such programs in FY2016 and each subsequent fiscal year; and
2. revise and expand provisions allowing a community health center to provide services at different locations, adjust its operating plan and budget, enter into arrangements with other centers to purchase supplies and services at reduced cost, and correct material failures in grant compliance.

Expedited licensing for biosimilar products.

Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products.
• Allows any person to file an abbreviated biological product application with the Secretary of Health and Human Services. Requires such applications to include information demonstrating a high degree of similarity or interchangeability between the biological product and the licensed biological product (reference product).
• Requires the Secretary to:
  1. approve an application and issue a license for a biosimilar product unless the Secretary finds and informs the applicant that the information in the application fails to demonstrate biosimilarity between the biological product and the reference product or the safety, purity, and potency of the biological product; and
  2. establish requirements for the efficient review, approval, suspension, and revocation of abbreviated biological product applications.
• Allows an applicant a determination as to the interchangeability of a product and its reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Grants market exclusivity to any biological product that is determined to be interchangeable for a specified period.
• Sets forth provisions governing patent infringement claims involving comparable biological products and legal remedies to expedite the adjudication of patent infringement disputes.
• Extends the period for approval of biological products to allow for studies of the use of new biological products in the pediatric population.

Collect data on birth defects and present to the public.

Directs the Centers for Disease Control and Prevention to carry out programs to:
• collect and analyze, and make available data on the causes of birth defects and on the incidence and prevalence of such defects;
• operate regional centers for the conduct of applied epidemiological research on the prevention of such defects;
• provide information and education to the public on the prevention of such defects;
• collect and analyze data by gender and by racial and ethnic group9/6/2004
• collect such data from birth and death certificates, hospital records, and such other sources; and
• (3) encourage States to establish or improve programs for the collection and analysis of epidemiological data on birth defects and to make the data available.