Merry Fristmas!
While Democrats and Progressives were asleep in their beds, and visions of impeachments and ANWAR-PatriotAct-slapdowns adanced in their heads, Majority Leader Bill "Ebenezer Scrooge" Frist was gleefully filling his eggnog with brandy and toasting the caribou in Alaska and NSA spooks - where ever they might be.
It took him five long years to finally pay off that chit to the BigPharma ghouls to whom he'd sold his soul to win his seat. He'd tried the front door (Thimerosal liability reform), backdoor (2002 Homeland Security Act), side-door (Smallpox and Anthrax Vaccine bills), even the chimney (no liability for FDA-approved drugs), but he just couldn't get that billion-dollar payback past those Democrats, and their RINO allies. He'd tried himself, used the exiting House Majority Leader, and that New Hampshire Yankee, Gregg. Weren't those crusty New Englanders considered the trustworthy and sane Republicans these days?
As his own political fortunes fell (over the rise of his monetary fortunes,) Frist knew his time to pay off his debt was quickly running out. So he took one last desperate shot, lassoed a bypassing, naive Freshman Senator, and shoved a new and improved super-bill into his pocket. See, he'd decided that perhaps he'd aimed too small, limiting those Americans BigPharma could screw to injured kids. Why not float the idea of a huge blanket liability for a whole bunch of drugs, and justify it in the name of global panemic prevention. Weaponized smallpox was just a little too far fetched for most Americans, but bird flu, there was something right out of Stephen King.
Unfortunately, even when his hapless Freshman submitted the bill, it sunk like last year's fruitcake. But clever Bill Grinch, er, Ebeneezer, bided his time. He didn't have much else to do since old Harry Reid had taken over the Senate, with the press hanging on him like tinsel on a tree. When the Defense Appropriations Bill came up and old man Stevens was determined to stick rocking horse pumps next to Ruldoph, Frist knew the time was now or never. Hopefully the Dems would be so miffed over Exxon in their winter wonderland, they'd overlook the huge payoff to BigPharma and erosion of basic 5th Amendment rights.
So let's drop the silly holiday theme, Dr. Frist's bet paid off, and we're all huge losers. The text of the more critical parts of the amendment is in the extended entry section, but the gist of it is that any and all "countermeasures" (vaccines, medications, etc.) used in the event of a biological attack, epidemic or pandemic are released from liability protections in all but the most eggregious situations (willful misconduct.) Who gets to determine these covered "countermeasures"? Who gets to decide what constitutes an "epidemic"? No, not Congress or the courts or even the NIH or CDC. This law cedes all of this to the Secretary of Health and Human Services.
Try googling "epidemic" and what do you find? In my first 50 hits, I learned there's currently an AIDS epidemic, an autism epidemic, an obesity epidemic, a HepC epidemic, a diabetes epidemic, a suicide epidemic, a meth epidemic, and even a handgun epidemic. Ignoring the last, I'd say that there are a few thousand drugs and vaccines which might fall under the total of those other "epidemics" should they be deemed "public health emergencies" as this bill provides.
I'm rather stunned that this bill has generated so little concern on the Left, though I have some thoughts on that, which I'm saving for a post later tonight (when the kids are in bed and I can drink the rest of the 2004 Stag's Leap Chardonnay which went untouched this weekend due to our own local epidemic of raging dysentery.)
The 2006 Defense Appropriations Bill is unaccessible for some reason on Thomas, but you can see Burr's earlier version of his bill (S. 1873), quietly appended in toto in the middle of the night by Dr. Frist early last week.
Read it and weep.
[Graphic via Linda Jones Enterprises]
SEC. 6. LIABILITY PROTECTIONS FOR PANDEMICS, EPIDEMICS, AND COUNTERMEASURES.
Part B of title III of the Public Health Service Act is amended by inserting after section 319F-2 (42 U.S.C. 247d-6b) the following:
`SEC. 319F-3. LIABILITY PROTECTIONS FOR PANDEMIC AND EPIDEMIC PRODUCTS AND SECURITY COUNTERMEASURES.
`(a) Authority- As provided in subsection (b), and subject to subsection (b)(1)(C), a manufacturer, distibutor, or administrator of a security countermeasure, or a qualified pandemic and epidemic product, described in subsection (b)(1)(A) or a health care provider shall be immune from suit or liability caused by or arising out of the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a security countermeasure, or a qualified pandemic and epidemic product, described in subsection (b)(1)(A).
`(b) Litigation Management-
`(1) LIMITATION ON CAUSE OF ACTION-
`(A) IN GENERAL-
`(i) IN GENERAL- No cause of action shall exist against a person described in subsection (a) for claims for loss of property, personal injury, or death arising out of, reasonably relating to, or resulting from the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a security countermeasure or qualified pandemic or epidemic product distributed, sold, purchased, donated, dispensed, prescribed, administered, or used in anticipation of and preparation for, in defense against, or in response to, or recovery from an actual or potential public health emergency that is a designated security countermeasure or a qualified pandemic or epidemic product by the Secretary in a declaration described in paragraph (2).
`(ii) RULE OF CONSTRUCTION- For purposes of this section, the phrase `arising out of, reasonably relating to, or resulting from' shall not be construed to apply to loss of property, personal injury, or death that has no alleged or potential causal relationship with the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a product described in clause (i).
`(B) RULE-
`(i) SUBSEQUENT INJURY- The protections set forth in subsection (a) and subparagraph (A) shall apply to all claims identified in subparagraph (A) that involve products distributed, sold, purchased, donated, dispensed, prescribed, administered, or used during the effective period set forth in the designation provided for in paragraph (2), regardless of the date of alleged injury.
`(ii) PRIVATE DONATION OR SALE- The protections set forth in subsection (a) and subparagraph (A) shall apply to all claims identified in subparagraph (A) that involve security countermeasures or qualified pandemic or epidemic products distributed, sold, purchased, donated, dispensed, prescribed, administered, or used during the effective period set forth in the designation provided for in paragraph (2) by a manufacturer through the commercial market, provided that the security countermeasures or the qualified pandemic or epidemic product are the security countermeasure or qualified pandemic or epidemic product described in a declaration described in paragraph (2) and the Secretary does not specifically prohibit such private donation or sale in such declaration.
`(C) POTENTIAL LIABILITY UPON DETERMINATION-
`(i) IN GENERAL- A manufacturer, distributor, administrator, or health care provider shall not be immune under subsection (a) or exempted from a cause of action under subparagraph (A) if the Secretary makes a determination as provided for in subparagraph (D).
`(ii) INVESTIGATION BY SECRETARY- A party seeking a determination under subparagraph (D) may petition the Secretary to investigate allegations against a manufacturer, distributor, administrator, or health care provider arising out of, relating to, or resulting from the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of products as provided for in subparagraph (A)(i). The decision to undertake such investigation shall be within the Secretary's discretion and shall not be subject to judicial review.
`(iii) RULE OF CONSTRUCTION- Nothing in this section shall be construed to abrogate or limit the application of subtitle II of chapter 5 and chapter 7 of title 5, United States Code (commonly known as the Administrative Procedure Act).
`(D) DETERMINATION BY SECRETARY-
`(i) IN GENERAL- In making a determination under this subparagraph, the Secretary, acting through an administrative law judge, must find clear and convincing evidence that--
`(I) the manufacturer, distributor, administrator, or health care provider violated a provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or this Act; and
`(II) in violating such Act, such manufacturer, distributor, administrator, or health care provider acted with willful misconduct.
`(ii) EFFECT OF DETERMINATION- If the Secretary finds such clear and convincing evidence under clause (i), the Secretary shall examine whether such willful misconduct to violate an Act under such clause--
`(I) caused the product to present a significant or unreasonable risk to human health; and
`(II) proximately caused the injury alleged by the party.
`(iii) NOTICE AND HEARING- Prior to the Secretary's making a determination under clause (i), the manufacturer, distributor, administrator, or health care provider shall have notice and a right to a formal hearing in accordance with section 556 of title 5, United States Code.
`(iv) EFFECT OF DETERMINATION- Subject to subsection (c), the sole exception to the immunity from suit and liability of manufacturers, distributors, administrators, or healthcare providers set forth in subsection (a) and subparagraph (A) shall be for actions against a manufacturer, distributor, administrator, or healthcare provider as provided in subparagraph (A).
`(v) JUDICIAL REVIEW- At any time prior to the 90th day following a determination by the Secretary under clause (i), any manufacturer, distributor, administrator, or health care provider named in such determination may file a petition with the United States Court District Court for the District of Columbia, for a judicial review of such determination. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by the Secretary for that purpose. The Secretary thereupon shall file in the court the record of the findings on which the Secretary based his or her determination. The filing of a petition under this clause shall automatically stay the Secretary's determination for the duration of the judicial proceeding. The sole parties to the judicial proceeding shall be the Secretary and the petitioner. Intervention by third parties in the judicial proceeding shall not be permitted. No subpoenas shall be issued nor shall other compulsory process apply. The court's review of a determination by the Secretary under this clause shall conform to the procedures for judicial review of administrative orders set forth in paragraphs (2) through (6) of section 701(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(f)) to the extent consistent with this section.
`(vi) TOLLING OF STATUTE OF LIMITATIONS- The computation of the statute of limitations for any action against a manufacturer, distributor, administrator, or health care provider described under this subparagraph shall not include any time occurring before the determination by the Secretary under this subparagraph.
`(vii) REGULATORY AUTHORITY- The Secretary, in consultation with the Attorney General, shall promulgate regulations defining what actions by a manufacturer, distributor, administrator, or healthcare provider of a security countermeasure or a qualified pandemic and epidemic product shall be deemed to constitute `willful misconduct' for purposes of clause (i). In promulgating such regulations, the Secretary shall consider the nature of the actual or potential public health emergency, the timing and extent of any vaccination or countermeasure program, and any other circumstances they deem significant, so that any civil actions permitted under this subsection will not adversely affect the public health. The Secretary may specify the period of time for which such regulations apply.
`(viii) EVIDENCE REQUIRED- The Secretary, in consultation with the Attorney General, shall promulgate regulations that require, in order to be a party under this section, that an individual present evidence that reasonably demonstrates that--
`(I) such individual has suffered a loss as a direct result of the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, or administration of a security countermeasure or qualified epidemic or pandemic product; and
`(II) the loss as described in subclause (I) was a direct result of the willful misconduct of the manufacturer, distributor, administrator, or health care provider in violating the Federal Food, Drug, and Cosmetic Act or this Act.
`(E) SCOPE- Subparagraph (C) shall apply regardless of whether the suit or liability described in subsection (a) or the claim described in subparagraph (A) arises from the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use by the Federal Government or by any person.
`(2) DECLARATION BY SECRETARY-
`(A) IN GENERAL- The Secretary may issue a declaration, pursuant to this paragraph, that an actual or potential public health emergency makes advisable the distribution, administration, or use of a security countermeasure or qualified pandemic or epidemic product.
`(B) SECURITY COUNTERMEASURE OR QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT- The Secretary shall specify in such declaration the security countermeasures or qualified pandemic or epidemic products to be sold by, purchased from, or donated by a manufacturer or drawn from the Strategic National Stockpile.
`(C) EFFECTIVE PERIOD- The Secretary shall specify in such declaration the beginning and the ending dates of the effective period of the declaration, which shall be not longer than 6 months. The Secretary may subsequently amend such declaration to shorten or extend such effective period, provided that the new ending data is after the date on which the declaration is amended.
`(D) PUBLICATION- The Secretary shall promptly publish each such declaration and amendment in the Federal Register.
`(c) Actions by the United States- Nothing in this section shall be construed to abrogate or limit any right, remedy, or authority that the United States or any agency thereof may possess under any other provision of law.
`(d) Definitions- In this section:
`(1) ADMINISTRATOR- The term `administrator' means a person employed by the State or local government, or their designee, who supervised or administered a program with respect to the administration, dispensing, distribution, or provision of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, supplied technical or scientific advice or assistance.
`(2) HEALTH CARE PROVIDER- The term `health care provider' means a person, including a volunteer, who distributes, prescribes, administers, dispenses, provides a facility to administer, or supervises or oversees the administration of a security countermeasure or a qualified pandemic or epidemic product, including persons who distribute, prescribe, administer, dispense, or provide a facility to administer in accordance with a designation under subsection (b)(2).
`(3) LOSS- The term `loss' means death, physical injury, or loss of or damage to property, including business interruption loss.
`(4) MANUFACTURER- The term `manufacturer' includes--
`(A) a contractor or subcontractor of a manufacturer;
`(B) a supplier of any product or service, research tool, or component to the manufacturer; and
`(C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
`(5) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT- The term `qualified pandemic or epidemic product' means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as such term is defined by section 351(i) of this Act) or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h))) designed, developed, modified, or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such pandemic or epidemic might otherwise cause or a serious or life-threatening disease or condition caused by such a product, that--
`(A) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act;
`(B) is a product for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the product will qualify for approval or licensing within 8 years after the date the Secretary makes a declaration under paragraph (2); or
`(C) is authorized for emergency use section 564 of the Federal Food, Drug, and Cosmetic Act, except that subsection (b) of such section shall not apply.
`(6) PARTY- The term `party' means an individual who can reasonably demonstrate to the Secretary that such individual has suffered a loss (as defined in paragraph (3)) as a direct result of the willful misconduct of a manufacturer, distributor, administrator, or health care provider.
`(7) PERSON- The term `person' includes an individual, partnership, corporation, association, entity, or public or private corporation, including a Federal, State, or local agency or department.
`(8) SECURITY COUNTERMEASURE- The term `security countermeasure' has the meaning given such term in section 319F-2(c)(1)(B).'.
SEC. 7. COMPENSATION.
Title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is amended by adding at the end the following:
`PART D--OTHER COMPENSATION PROGRAMS
`SEC. 271. COVERED COUNTERMEASURES PROGRAM.
`(a) In General- If the Secretary issues a Proclamation stating that there is a critical public health need for a covered individual to receive a covered countermeasure during the effective period of the Proclamation, the Secretary shall establish a process to provide compensation to such covered individuals for a covered injury, consistent with the Smallpox Emergency Personnel Protection program under part C.
`(b) Definition- For purposes of this section:
`(1) COVERED COUNTERMEASURE- The term `covered countermeasure' means a qualified pandemic or epidemic (as defined in section 319F-3(c)(5)) or a security countermeasure (as defined in section 319F-2(c)(1)(B)) specified in the Proclamation.
`(2) COVERED INDIVIDUAL- The term `covered individual' means an individual--
`(A) who is a health care worker, law enforcement officer, firefighter, security personnel, emergency medical personnel, other public health or safety personnel, or support personnel for such occupational specialties;
`(B) who is or will be functioning in a role identified in a State, local, or Department of Health and Human Services emergency response plan approved by the Secretary;
`(C) who has volunteered and been selected to be a member of an emergency response plan; and
`(D) to whom a covered countermeasure is administered pursuant to such approved plan during the effective period of the Proclamation and prior to the time at which the Secretary declares a public health emergency pursuant to section 319 related to a covered countermeasure specified in the Proclamation.
`(3) COVERED INJURY- The term `covered injury' means an injury, disability, illness, condition, or death (other than a minor injury such as minor scarring or minor local reaction) determined by the Secretary to have been sustained by a covered individual as the direct result of administration to the individual of a covered countermeasure.
`(4) EFFECTIVE PERIOD OF THE PROCLAMATION- The term `effective period of the Proclamation' means the effective period specified in the Proclamation, unless extended by the Secretary.
`(5) EMERGENCY RESPONSE PLAN- The term `emergency response plan' or `plan' means a response plan detailing actions to be taken in preparation for a pandemic, epidemic, or biological, chemical, nuclear agent or toxin that presents, or may present, a public health emergency.
`(6) PROCLAMATION- The term `Proclamation' means a Proclamation regarding the critical public health need for the administration of a covered countermeasure issued by the Secretary and published in the Federal Register. Such Proclamation shall specify the specific covered countermeasure recommended for administration.
`(c) Rule of Construction- Nothing in this section shall be construed to require the creation of a compensation program if the covered injuries are only minor injuries consistent with section (b)(3).'.