Nathan Deal on Health Care
Republican Governor; previously Representative (GA-10)
Medicaid expansion costs too much
The cost of Medicaid has grown from $2.6 billion in FY2013 to $3.1 billion in FY2017. Medicaid and PeachCare spending per Georgia family amounts to $1,258 per annum. When federal and other costs are added to this number, it is at least $4,365 each year.
And that's without expansion. Had we elected to expand Medicaid, it would have required us to include approximately $209 million in this upcoming year's budget alone and that number would only continue to grow exponentially.
Source: 2016 State of the State speech to Georgia legislature
, Jan 13, 2016
Affordable Care Act is waste of money
To demonstrate our compliance with the mandates of the Affordable Care Act, we must devote $2.1 million in FY2017 budget just to turn in the paper work. When you combine the cost of federal dollars to that total, it is $4.4 million. In other words, this
is just what it costs to tell the IRS that everyone in our State Health Benefit Plan and Medicaid program is covered. I can assure you that those funds could have been put to better use than on bureaucratic paperwork.
Source: 2016 State of the State speech to Georgia legislature
, Jan 13, 2016
Guaranteed ER room treatment means excessive ER visits
Gov. Nathan Deal has often called on Congress to reconsider the Affordable Care Act. But on Monday evening, he pushed his former Washington colleagues to revisit a separate health care law that fewer politicians openly critique. The Emergency Medical
Treatment and Labor Act is a 1986 law that requires hospitals to provide emergency health care treatment to anyone who needs it, regardless of citizenship or their ability to pay. It's provided life-saving care to countless people, but it's also strained
hospital resources and turned emergency rooms into the first stop, instead of a last resort, for some.
"If they really want to get serious about lowering the cost of health care in this country, they would revisit another federal statute," Deal told
the crowd. "It came as a result of bad facts, and bad facts make bad law. I think we should be able to figure out ways to deal with those situations but not have the excessive costs associated with unnecessary visits to the emergency room."
Source: Atlanta Journal Constitution: 2014 Georgia governor's race
, Feb 25, 2014
Refuses to expand Medicaid rolls under ObamaCare
The Emergency Medical Treatment and Labor Act of 1986, which requires hospitals to provide emergency health care treatment to anyone who needs it, regardless of citizenship or their ability to pay, is an important topic for Deal,
given that many hospitals in rural Georgia are caught in the financial pinch caused by the governor's refusal to expand Medicaid rolls, and the Affordable Care Act's reduction of federal cash for indigent care.
Source: Atlanta Journal Constitution: 2014 Georgia governor's race
, Feb 25, 2014
ObamaCare will cost Georgia $2.5B over next ten years
The overreaching federal health care legislation will greatly add to the burden that we face. In fact, it will add approximately 650,000 Georgians to the Medicaid rolls. This mandated expansion of service will cost Georgia Medicaid an additional
$2.5 billion in State funds alone over the next ten years. The Obama Administration has placed onerous Maintenance of Effort requirements as well, which have severely tied our hands with respect to managing our state Medicaid program.
Source: 2011 Georgia State of the State Address
, Jan 12, 2011
Voted NO on regulating tobacco as a drug.
Congressional Summary:Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration (FDA). Defines a tobacco product as any product made or derived from tobacco that is intended for human consumption. Excludes from FDA authority the tobacco leaf and tobacco farms.
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.
Reference: Family Smoking Prevention and Tobacco Control Act;
; vote number 2009-H187
on Apr 2, 2009
Voted NO on expanding the Children's Health Insurance Program.
Proponent's argument to vote Yes:
- 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.
Reference: SCHIP Reauthorization Act;
; vote number 2009-H016
on Jan 14, 2009
Voted YES on overriding veto on expansion of Medicare.
Pres. GEORGE W. BUSH's veto message (argument to vote No):
- 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:In addition, H.R. 6331 would delay important reforms like the Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies competitive bidding program. Changing policy in mid-stream is also confusing to beneficiaries who are receiving services from quality suppliers at lower prices. In order to slow the growth in Medicare spending, competition within the program should be expanded, not diminished.
- 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.
Reference: Medicare Improvements for Patients and Providers Act;
; vote number 2008-H491
on Jul 15, 2008
Voted NO on giving mental health full equity with physical health.
- Paul Wellstone Mental Health and Addiction Equity Act of 2008: Requires group health plans to apply the same treatment limits on mental health or substance-related disorder benefits as they do for medical and surgical benefits (parity requirement).
- Genetic Information Nondiscrimination Act of 2008: Prohibits a group health plan from adjusting premium or contribution amounts for a group on the basis of genetic information.
SUPPORTER'S ARGUMENT FOR VOTING YES:Rep. PALLONE. This is a comprehensive bill which will establish full mental health and addiction care parity. The Mental Health Parity Act of 1996 authorized for 5 years partial parity by mandating that the annual and lifetime dollar limit for mental health treatment under group health plans offering mental health coverage be no less than that for physical illnesses. This bill requires full parity and also protects against discrimination by diagnosis.
OPPONENT'S ARGUMENT FOR VOTING NO:Rep. DEAL of Georgia: I am a supporter of the concept of mental health parity, but this bill before us today is not the correct approach. This path will raise the price of health insurance, and would cause some to lose their health insurance benefits and some employers to terminate mental health benefits altogether.
The bill's focus is also overly broad. Our legislation should focus on serious biologically-based mental disorders like schizophrenia and bipolar disorder, not on jet lag and caffeine addiction, as this bill would include. There are no criteria for judicial review, required notice and comment, or congressional review of future decisions.
I would ask my colleagues to vote "no" today so that we can take up the Senate bill and avoid a possible stalemate in a House-Senate conference on an issue that should be signed into law this Congress.
LEGISLATIVE OUTCOME:Bill passed House, 268-148
Reference: Mental Health and Addiction Equity Act;
; vote number 08-HR1424
on Mar 5, 2008
Voted NO on Veto override: Extend SCHIP to cover 6M more kids.
OnTheIssues Explanation: This vote is a veto override of the SCHIP extension (State Children's Health Insurance Program). The bill passed the House 265-142 on 10/25/07, and was vetoed by Pres. Bush on 12/12/07.
CONGRESSIONAL SUMMARY: This Act would enroll all 6 million uninsured children who are eligible, but not enrolled, for coverage under existing programs.
PRESIDENT'S VETO MESSAGE: 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. My Administration strongly supports reauthorization of SCHIP. [But this bill, even with changes, does not meet the requirements I outlined].
It would still shift SCHIP away from its original purpose by covering adults. It would still include coverage of many individuals with incomes higher than the median income. It would still result in government health care for approximately
2 million children who already have private health care coverage.
SUPPORTER'S ARGUMENT FOR VOTING YES:Rep. DINGELL: This is not a perfect bill, but it is an excellent bipartisan compromise. The bill protects health insurance coverage for some 6 million children who now depend on SCHIP. It provides health coverage for 3.9 million children who are eligible, yet remain uninsured. Together, this is a total of better than 10 million young Americans who, without this legislation, would not have health insurance.
The bill makes changes to accommodate the President's stated concerns.
LEGISLATIVE OUTCOME:Veto override failed, 260-152 (2/3rds required)
Reference: SCHIP Extension;
Bill Veto override on H.R.3963
; vote number 08-HR3963
on Jan 23, 2008
- It terminates the coverage of childless adults in 1 year.
- It prohibits States from covering children in families with incomes above $51,000.
- It contains adequate enforcement to ensure that only US citizens are covered.
- It encourages securing health insurance provided through private employer.
Voted NO on adding 2 to 4 million children to SCHIP eligibility.
Allows State Children's Health Insurance Programs (SCHIP), that require state legislation to meet additional requirements imposed by this Act, additional time to make required plan changes. Pres. Bush vetoed this bill on Dec. 12, 2007, as well as a version (HR976) from Feb. 2007.
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]:
- It terminates the coverage of childless adults.
- 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.
- 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.
Reference: Children's Health Insurance Program Reauthorization Act;
Bill H.R. 3963
; vote number 2007-1009
on Oct 25, 2007
Voted NO on requiring negotiated Rx prices for Medicare part D.
Would require negotiating with pharmaceutical manufacturers the prices that may be charged to prescription drug plan sponsors for covered Medicare part D drugs.
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.
Reference: Medicare Prescription Drug Price Negotiation Act;
Bill HR 4 ("First 100 hours")
; vote number 2007-023
on Jan 12, 2007
Voted YES on denying non-emergency treatment for lack of Medicare co-pay.
Vote to pass a resolution, agreeing to S. AMDT. 2691 that removes the following provisions from S 1932:
Reference: Reconciliation resolution on the FY06 budget;
Bill H Res 653 on S. AMDT. 2691
; vote number 2006-004
on Feb 1, 2006
- Allows hospitals to refuse treatment to Medicaid patients when they are unable to pay their co-pay if the hospital deems the situation to be a non-emergency
- Excludes payment to grandparents for foster care
Voted YES on limiting medical malpractice lawsuits to $250,000 damages.
Vote to pass a bill that would limit the awards that plaintiffs and their attorneys could be given in medical malpractice cases. The bill would limit non-economic damages, including physical and emotional pain to $250,000. The bill would also limit punitive damages to $250,000 or double economic damages, whichever amount is greater. Punitive damages would be banned against makers and distributors of medical products if the Food and Drug Administration approved those products. The bill would call for all states to set damage caps but would not block existing state statutory limits. The bill would cap attorneys' contingency fees to 40% of the first $50,000 in damages; 33.3% of the next $50,000; 25% of the next $500,000; and 15% of any amount in excess of $600,000.
Reference: Medical Malpractice Liability Limitation bill;
Bill HR 4280
; vote number 2004-166
on May 12, 2004
Voted YES on limited prescription drug benefit for Medicare recipients.
Medicare Prescription Drug and Modernization Act of 2003: Vote to adopt the conference report on the bill that would create a prescription drug benefit for Medicare recipients. Starting in 2006, prescription coverage would be made available through private insurers to seniors. Seniors would pay a monthly premium of an estimated $35 in 2006. Individuals enrolled in the plan would cover the first $250 of annual drug costs themselves, and 25 percent of all drug costs up to $2,250. The government would offer a fallback prescription drug plan in regions were no private plans had made a bid.Over a 10 year time period medicare payments to managed care plans would increase by $14.2 billion. A pilot project would begin in 2010 in which Medicare would compete with private insurers to provide coverage for doctors and hospitals costs in six metropolitan areas for six years. The importation of drugs from Canada would be approved only if HHS determines there is no safety risks and that consumers would be saving money.
Reference: Bill sponsored by Hastert, R-IL;
; vote number 2003-669
on Nov 22, 2003
Voted NO on allowing reimportation of prescription drugs.
Pharmaceutical Market Access Act of 2003: Vote to pass a bill that would call for the Food and Drug Administration to begin a program that would permit the importation of FDA-approved prescription drugs from Australia, Canada, the European Union, Iceland, Israel, Japan, Lichtenstein, New Zealand, Norway, Switzerland and South Africa.
Reference: Bill sponsored by Gutknecht, R-MN;
; vote number 2003-445
on Jul 24, 2003
Voted YES on small business associations for buying health insurance.
Vote to pass a bill that would permit the creation of association health plans through which small companies could group together to buy insurance for their employees. Association health plans that cover employees in several states would be excused from many individual state insurance regulations but would be regulated by the Labor Department.
Reference: Small Business Health Fairness Act;
Bill HR 660
; vote number 2003-296
on Jun 19, 2003
Voted YES on capping damages & setting time limits in medical lawsuits.
Help Efficient, Accessible, Low Cost, Timely Healthcare (HEALTH) Act of 2003: To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system. Limits the availability of punitive damages, and sets a 3-year limit for suing.
Reference: Bill sponsored by Greenwood, R-PA;
Bill HR 5
; vote number 2003-64
on Mar 13, 2003
Voted YES on allowing suing HMOs, but under federal rules & limited award.
Vote to adopt an amendment that would limit liability and damage awards when a patient is harmed by a denial of health care. It would allow a patient to sue a health maintenance organization in state court but federal, not state, law would govern.
Bill HR 2563
; vote number 2001-329
on Aug 2, 2001
Voted YES on subsidizing private insurance for Medicare Rx drug coverage.
HR 4680, the Medicare Rx 2000 Act, would institute a new program to provide voluntary prescription drug coverage for Medicare beneficiaries through subsidies to private plans. The program would cost an estimated $40 billion over five years and would go into effect in fiscal 2003.
Reference: Bill sponsored by Thomas, R-CA;
Bill HR 4680
; vote number 2000-357
on Jun 28, 2000
Voted YES on banning physician-assisted suicide.
Vote on HR 2260, the Pain Relief Promotion Act of 1999, would ban the use of drugs for physician-assisted suicide. The bill would not allow doctors to give lethal prescriptions to terminally ill patients, and instead promotes "palliative care," or aggressive pain relief techniques.
Reference: Bill sponsored by Hyde, R-IL;
Bill HR 2260
; vote number 1999-544
on Oct 27, 1999
Voted YES on establishing tax-exempt Medical Savings Accounts.
The bill allows all taxpayers to create a tax-exempt account for paying medical expenses called a Medical Savings Account [MSA]. Also, the measure would allow the full cost of health care premiums to be taken as a tax deduction for the self-employed and taxpayers who are paying for their own insurance. The bill would also allow the establishment of "HealthMarts," regional groups of insurers, health care providers and employers who could work together to develop packages for uninsured employees. Another provision of the bill would establish "association health plan," in which organizations could combine resources to purchase health insurance at better rates than they could separately.
Reference: Bill sponsored by Talent, R-MO;
Bill HR 2990
; vote number 1999-485
on Oct 6, 1999
Limit anti-trust lawsuits on health plans and insurers.
Deal co-sponsored limiting anti-trust lawsuits on health plans and insurers
OFFICIAL CONGRESSIONAL SUMMARY:
- Delineates the relationship between the antitrust laws and negotiations between groups of health care professionals and health plans and health care insurance issuers.
- Applies the "rule of reason" standard to negotiations between a health plan and two or more physicians.
- Awards attorneys' fees to a substantially prevailing plaintiff only when the defendant's conduct was unreasonable or in bad faith.
- Prohibits tying arrangements (linking the participation in one product line to participation in another) between a health plan and health care professional.
- Excludes from this Act any negotiations or agreements including Medicare, Medicaid, SCHIP, or other federal programs.
EXCERPTS FROM CONGRESSIONAL FINDINGS:
Congress finds the following:
- A large number of Americans receive their health care coverage from managed health care plans.
- The market power of insurance companies has increased
tremendously since the early 1990's, due to mergers and acquisitions.
- Health plans improperly manipulate the practice of medicine through such mechanisms as inappropriately making medical necessity determinations, and knowingly denying and delaying payment.
- The intent of the antitrust laws is to encourage competition and protect the consumer, and the current per se standard for enforcing the antitrust laws in the health care field frequently does not achieve these objectives.
- An application of the "rule of reason" will tend to promote both competition and high-quality patient care.
- In any action under the antitrust laws challenging a health plan, conduct shall not be deemed illegal per se, but shall be judged on the basis of its reasonableness, taking into account all relevant factors affecting competition and proposed contract terms.
LEGISLATIVE OUTCOME: Referred to the House Committee on the Judiciary; never called for a House vote.
Source: Health Care Antitrust Improvements Act (H.R.3897) 02-HR3897 on Mar 7, 2002
Rated 0% by APHA, indicating a anti-public health voting record.
Deal scores 0% by APHA on health issues
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.
Source: APHA website 03n-APHA on Dec 31, 2003
Opposes government-run healthcare.
Deal opposes the CC survey question on government-run healthcare
The Christian Coalition voter guide [is] one of the most powerful tools Christians have ever had to impact our society during elections. This simple tool has helped educate tens of millions of citizens across this nation as to where candidates for public office stand on key faith and family issues.
The CC survey summarizes candidate stances on the following topic: "Federal government run health care system"
Source: Christian Coalition Survey 10-CC-q5 on Aug 11, 2010
Defund, repeal, & replace federal care with free market.
Deal signed the Contract From America
The Contract from America, clause 7. Defund, Repeal, & Replace Government-run Health Care:
Defund, repeal and replace the recently passed government-run health care with a system that actually makes health care and insurance more affordable by enabling
Source: The Contract From America 10-CFA07 on Jul 8, 2010
Loosen "one-size-fits-all" approach to Medicaid.
Deal signed Letter to Pres. Obama from 32 Governors
As Governors, we are writing to you regarding the excessive constraints placed on us by healthcare-related federal mandates. One of our biggest concerns continues to be the Maintenance of Effort (MOE) provisions of the Patient Protection and Affordable Care Act, which prevent states from managing their Medicaid programs for their unique Medicaid populations. We ask for your immediate action to remove these MOE requirements so that states are once again granted the flexibility to control their program costs and make necessary budget decisions.
Every Governor, Republican and Democrat, will face unprecedented budget challenges in the coming months. Efforts to regulate state operations impose greater uncertainty on our budgets for oncoming years and create a perfect storm when coupled with the current state of the economy.
Health and education are the primary cost drivers for most state budgets. Medicaid enrollment is up. Revenues are down. States are unable to afford the current Medicaid program, yet our hands are tied by the MOE requirements. The effect of the federal requirements is unconscionable; the federal requirements force Governors to cut other critical state programs, such as education, in order to fund a "one-size-fits-all" approach to Medicaid. Again, we ask you to lift the MOE requirements so that states may make difficult budget decisions in ways that reflect the needs of their residents.
Source: Letter to Obama from 32 Governors 110107-Gov on Jan 7, 2011
Expedited licensing for biosimilar products.
Deal signed Promoting Innovation & Access to Life-Saving Medicine Act
Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products.
Source: S.726&HR.1427 2009-S726 on Mar 11, 2009
- 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:
- 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
- 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.
Page last updated: Feb 20, 2017