Florida Senate - 2019                        COMMITTEE AMENDMENT
       Bill No. SB 1528
       
       
       
       
       
       
                                Ì958184DÎ958184                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  03/25/2019           .                                
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       The Committee on Health Policy (Bean) recommended the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 381.02035, Florida Statutes, is created
    6  to read:
    7         381.02035 Canadian Prescription Drug Importation Program.—
    8         (1)PROGRAM ESTABLISHED.—The Agency for Health Care
    9  Administration shall establish a program for the importation of
   10  safe and effective prescription drugs from Canada which have the
   11  highest potential for cost savings to the state.
   12         (2) DEFINITIONS.—As used in this section, the term:
   13         (a)“Agency” means the Agency for Health Care
   14  Administration.
   15         (b)“Canadian supplier” means a manufacturer, wholesale
   16  distributor, or pharmacy appropriately licensed or permitted
   17  under Canadian law to manufacture, distribute, or dispense
   18  prescription drugs.
   19         (c)“Drug” or “prescription drug” has the same meaning as
   20  “prescription drug” in s. 499.003.
   21         (d)“Federal Act” means the Federal Food, Drug, and
   22  Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
   23  as amended by the Drug Quality and Security Act, 21 U.S.C. 351
   24  et seq.
   25         (e)“Importer” means a wholesale distributor, pharmacy, or
   26  pharmacist importing prescription drugs into this state under
   27  the program.
   28         (f)“Pharmacist” means a person who holds an active and
   29  unencumbered license to practice pharmacy pursuant to chapter
   30  465.
   31         (g)“Program” means the Canadian Prescription Drug
   32  Importation Program.
   33         (h) “Track-and-trace” means the product-tracing process for
   34  the components of the pharmaceutical distribution supply chain
   35  as described in Title II of the Drug Quality and Security Act,
   36  Drug Supply Chain Security Act, 21 U.S.C. 351 et seq.
   37         (i)“Vendor” means the entity contracted by the agency to
   38  manage specified functions of the program.
   39         (3)ELIGIBLE CANADIAN SUPPLIERS.—A Canadian supplier may
   40  export drugs into this state under the program if the supplier
   41  meets all of the following requirements:
   42         (a)Complies fully with relevant Canadian federal and
   43  provincial laws and regulations.
   44         (b)Complies fully with the Federal Act, including all
   45  other state and federal law and regulations relating to the
   46  track-and-trace requirements at the package level.
   47         (c)Submits evidence at time of contract award and
   48  throughout the contract term of a surety bond or comparable
   49  security arrangement from this state or any other state in the
   50  United States in the minimum amount of $1 million. The agency
   51  shall reevaluate and adjust the amount of the bond annually,
   52  based on program volume. The surety bond or comparable security
   53  arrangement must include the State of Florida as a beneficiary.
   54  In lieu of the surety bond, the supplier may provide a
   55  comparable security arrangement such as an irrevocable letter of
   56  credit or a deposit into a trust account or financial
   57  institution which includes the State of Florida as a
   58  beneficiary. The purposes of the bond or other security
   59  arrangements for the program are to:
   60         1.Ensure payment of any administrative penalties imposed
   61  by the agency or any other state agency under the contract when
   62  the supplier fails to pay within 30 days after assessment;
   63         2.Ensure performance of contractual and statutory
   64  obligations by the supplier through use of a bond or other
   65  comparable security arrangements to receive payment of any other
   66  costs or fees incurred by the agency, the state, or other
   67  entities acting on behalf of the state if the supplier is non
   68  compliant with its contractual and statutory obligations. If the
   69  supplier is assessed a penalty under the program and fails to
   70  pay within 30 days after that assessment, the agency, the state,
   71  or an entity acting on behalf of the state may file a claim for
   72  reimbursement against the bond or other comparable security
   73  arrangement; and
   74         3.Allow for claims to be made against the bond or other
   75  comparable security arrangements for up to 1 year after the
   76  supplier’s contract under the program has ended with the agency
   77  or the state, the supplier’s license is no longer valid, or the
   78  program has ended, whichever occurs last.
   79  
   80  A surety bond or other comparable security arrangement is
   81  required regardless of the time of bid or negotiation process
   82  used by the agency or the type of final contract or agreement
   83  executed for services.
   84         (d)Is identified by the vendor as eligible to participate
   85  in the program.
   86         (e) Submits evidence at the time of contract award and
   87  throughout the contract term of a surety bond or comparable
   88  security arrangement from this state or any other state in the
   89  United States in the minimum amount of $1 million. The agency
   90  shall reevaluate and adjust the amount of the bond annually,
   91  based on program volume. The surety bond or comparable security
   92  arrangement must include the State of Florida as a beneficiary.
   93  In lieu of the surety bond, the supplier may provide a
   94  comparable security arrangement such as an irrevocable letter of
   95  credit or a deposit into a trust account or financial
   96  institution which includes the State of Florida as a
   97  beneficiary. The purposes of the bond or other security
   98  arrangements for the program are to:
   99         1.Indemnify the supplier in the event that any civil or
  100  criminal legal action is brought by the state, the agency, any
  101  other state agency, or private individuals or entities against
  102  the supplier because of the supplier’s failure to perform under
  103  the contract, including, but not limited to, causes of actions
  104  for personal injury, negligence, and wrongful death;
  105         2.Ensure payment by the supplier of legal judgements and
  106  claims that have been awarded to the state, the agency, other
  107  entities acting on behalf of the state, individuals, or
  108  organizations if the supplier is assessed a final judgement or
  109  other monetary penalty in a court of law for a civil or criminal
  110  action related to participation in the program. The bond or
  111  comparable security arrangement may be accessed if the supplier
  112  fails to pay any judgement or claim within 60 days after final
  113  judgement; and
  114         3.Allow for civil and criminal litigation claims to be
  115  made against the bond or other comparable security arrangements
  116  for up to 1 year after the supplier’s contract under the program
  117  has ended with the agency or the state, the supplier’s license
  118  is no longer valid, or the program has ended, whichever occurs
  119  last.
  120         (4)ELIGIBLE IMPORTERS.—
  121         (a)The following entities or persons may import
  122  prescription drugs from a Canadian supplier under the program:
  123         1.A wholesale distributor.
  124         2.A pharmacy.
  125         3.A pharmacist.
  126         (b)An eligible importer must meet all of the following
  127  requirements at time of contract award and throughout the
  128  contract term:
  129         1.Register with the vendor before importing drugs into the
  130  state under the program and be deemed in compliance with all
  131  requirements, including any relevant provisions of the Federal
  132  Act.
  133         2.Submit evidence at time of contract award and throughout
  134  the contract term of a surety bond or other comparable security
  135  arrangement from this state or any other state in the United
  136  States in the amount of $1 million. The surety bond or
  137  comparable security arrangement must include the State of
  138  Florida as a beneficiary. In lieu of the surety bond, the
  139  supplier may provide a comparable security agreement such as an
  140  irrevocable letter of credit or a deposit into a trust account
  141  or financial institution which includes the State of Florida as
  142  a beneficiary, payable to the State of Florida. The purposes of
  143  the bond or other security arrangements for the program are to:
  144         a.Ensure payment of any administrative penalties imposed
  145  by the agency or any other state agency under the contract when
  146  the importer fails to pay within 30 days after assessment;
  147         b.Ensure performance of contractual and statutory
  148  obligations by the importer through use of a bond or other
  149  comparable security arrangements to receive payment of any other
  150  costs or fees incurred by the agency, the state, or other
  151  entities acting on behalf of the state if the importer is non
  152  compliant with its contractual and statutory obligations. If the
  153  importer is assessed a penalty under the program and fails to
  154  pay within 30 days after that assessment, the agency, the state,
  155  or an entity acting on behalf of the state may file a claim for
  156  reimbursement against the bond or other comparable security
  157  arrangement; and
  158         c.Allow for claims to be made against the bond or other
  159  comparable security arrangements for up to 1 year after the
  160  importer’s contract under the program has ended with the agency
  161  or the state, the importer’s license is no longer valid, or the
  162  program has ended, whichever occurs last.
  163  
  164  A surety bond or comparable document is required regardless of
  165  the time of bid or negotiation process used by the agency or the
  166  type of final contract or agreement executed for services.
  167         (c) Submits evidence at the time of contract award and
  168  throughout the contract term of a surety bond or comparable
  169  security arrangement from this state or any other state in the
  170  United States in the minimum amount of $1 million. The agency
  171  shall reevaluate and adjust the amount of the bond annually,
  172  based on program volume. The surety bond or comparable security
  173  arrangement must include the State of Florida as a beneficiary.
  174  In lieu of the surety bond, the supplier may provide a
  175  comparable security agreement such as an irrevocable letter of
  176  credit or a deposit into a trust account or financial
  177  institution which includes the State of Florida as a
  178  beneficiary, payable to the State of Florida. The purposes of
  179  the bond or other security arrangements for the program are to:
  180         1.Ensure participation of the supplier in any civil or
  181  criminal legal action by the state, the agency, any other state
  182  agency, or private individuals or entities against the supplier
  183  because of the supplier’s failure to perform under the contract,
  184  including, but not limited to causes of actions for personal
  185  injury, negligence, and wrongful death;
  186         2.Ensure payment by the supplier through the use of a bond
  187  or other comparable security arrangements of legal judgements
  188  and claims that have been awarded to the agency, the state,
  189  other entities acting on behalf of the state, individuals, or
  190  organizations if the supplier is assessed a final judgement or
  191  other monetary penalty in a court of law for a civil or criminal
  192  action under the program. The bond or comparable security
  193  arrangement will be accessed if the supplier fails to pay any
  194  judgement or claim within 60 days after final judgement; and
  195         3.Allow for civil and criminal litigation claims to be
  196  made against the bond or other comparable security arrangements
  197  for up to 1 year after the supplier’s contract under the program
  198  has ended with the agency or the state, the supplier’s license
  199  is no longer valid, or the program has ended, whichever occurs
  200  last.
  201         (5)IMPORTATION PROCESS.—
  202         (a)The agency shall contract with a vendor to provide
  203  services under the program. The vendor must submit evidence of a
  204  surety bond with any bid or initial contract negotiation
  205  documents and maintain documentation of evidence of such a bond
  206  with the agency throughout the throughout the contract term of a
  207  surety bond from this state or any other state in the United
  208  States in the same amount of $1 million. The surety bond or
  209  comparable security arrangement must include the State of
  210  Florida as a beneficiary. In lieu of the surety bond, the
  211  supplier may provide a comparable security agreement such as an
  212  irrevocable letter of credit or a deposit into a trust account
  213  or financial institution which includes the State of Florida as
  214  a beneficiary, payable to the State of Florida. The purposes of
  215  the bond or other security arrangements for the program are to:
  216         1.Ensure payment of any administrative penalties imposed
  217  by the agency or any other state agency under the contract when
  218  the vendor fails to pay within 30 days after assessment;
  219         2.Ensure performance of contractual and statutory
  220  obligations by the vendor through use of a surety bond or other
  221  comparable security arrangements to receive payment of any other
  222  costs or fees incurred by the agency, the state, or other
  223  entities acting on behalf of the state if the vendor is non
  224  compliant with its contractual and statutory obligations. If the
  225  vendor is assessed a penalty under the program and fails to pay
  226  within 30 days after that assessment, the agency, the state, or
  227  an entity acting on behalf of the state may file a claim for
  228  reimbursement against the bond or other comparable security
  229  arrangement; and
  230         3.Allow for claims to be made against the bond or other
  231  comparable security arrangements for up to 1 year after the
  232  vendor’s contract under the program has ended with the agency or
  233  the state, the importer’s license is no longer valid, or the
  234  program has ended, whichever occurs last.
  235  
  236  A surety bond or comparable document is required regardless of
  237  the time of bid or negotiation process used by the agency or the
  238  type of final contract or agreement executed for services.
  239         (b)Submits evidence at the time of contract award and
  240  throughout the contract term of a surety bond or comparable
  241  security arrangement from this state or any other state in the
  242  United States in the minimum amount of $1 million. The agency
  243  shall reevaluate and adjust the amount of the bond annually,
  244  based on program volume. The surety bond or comparable security
  245  arrangement must include the State of Florida as a beneficiary.
  246  In lieu of the surety bond, the supplier may provide a
  247  comparable security arrangement such as an irrevocable letter of
  248  credit or a deposit into a trust account or financial
  249  institution which names the State of Florida as a beneficiary.
  250  The purposes of the bond or other security arrangements for the
  251  program are to:
  252         1.Ensure participation of the vendor in any civil or
  253  criminal legal action by the state, the agency, any other state
  254  agency, or private individuals or entities against the vendor
  255  because of the vendor’s failure to perform under the contract,
  256  including, but not limited to causes of actions for personal
  257  injury, negligence, and wrongful death;
  258         2.Ensure payment by the vendor through the use of a bond
  259  or other comparable security arrangements of legal judgements
  260  and claims that have been awarded to the agency, the state,
  261  other entities acting on behalf of the state, individuals, or
  262  organizations if the vendor is assessed a final judgement or
  263  other monetary penalty in a court of law for a civil or criminal
  264  action under the program. The bond or comparable security
  265  arrangement will be accessed if the vendor fails to pay any
  266  judgement or claim within 60 days after final judgement; and
  267         3.Allow for civil and criminal litigation claims to be
  268  made against the bond or other comparable security arrangements
  269  for up to 1 year after the vendor’s contract under the program
  270  has ended with the agency or the state, the vendor’s license is
  271  no longer valid, or the program has ended, whichever occurs
  272  last.
  273         (c)The vendor shall provide all of the following services
  274  at a minimum:
  275         1.Develop a list every 3 month of drugs that have the
  276  highest potential for cost savings to the state if imported from
  277  Canada. In developing the list, the vendor shall consider, at a
  278  minimum, which drugs will provide the greatest cost savings to
  279  the state, including drugs for which there are shortages,
  280  specialty drugs, and high-volume drugs. The agency may direct
  281  the vendor to revise the list, as necessary.
  282         2.Identify Canadian suppliers that are in full compliance
  283  with relevant Canadian federal and provincial laws and
  284  regulations and the Federal Act and who have agreed to export
  285  drugs identified on the list. The vendor must verify that such
  286  Canadian suppliers meet all of the requirements of the program
  287  and will export drugs at prices that will provide cost savings
  288  to the state while meeting or exceeding the track-and-trace
  289  federal and state laws and regulations.
  290         3.Contract with such eligible Canadian suppliers, or
  291  facilitate contracts between eligible importers and Canadian
  292  suppliers, to import drugs under the program.
  293         4.Maintain a listing of all registered importers that
  294  participate in the program.
  295         5.Ensure compliance with Title II of the federal Drug
  296  Quality and Security Act P.L. 113-54 by all suppliers, importers
  297  and other distributors and participants in the program.
  298         6.Assist the agency with the annual report as required in
  299  subsection (12) and provide any information requested by the
  300  agency for such report on a timely basis.
  301         (d)The profit margin and administrative fees of any
  302  participating wholesaler, pharmacy, or pharmacist on imported
  303  drug products is limited to a maximum amount as specified
  304  annually in the General Appropriations Act.
  305         (6)ELIGIBLE PRESCRIPTION DRUGS.—Eligible importers may
  306  import a drug from an eligible Canadian supplier if:
  307         (a)The drug meets the United States Food and Drug
  308  Administration’s standards related to safety, effectiveness,
  309  misbranding, and adulteration;
  310         (b)Importing the drug would not violate the patent laws of
  311  the United States;
  312         (c)Importing the drug is expected to generate cost
  313  savings; and
  314         (d)The drug is not:
  315         1.A controlled substance as defined in 21 U.S.C. s. 802;
  316         2.A biological product as defined in 42 U.S.C. s. 262;
  317         3.An infused drug;
  318         4.An intravenously injected drug;
  319         5.A drug that is inhaled during surgery; or
  320         6.A drug that is a parenteral drug, the importation of
  321  which is determined by the United States Secretary of Health and
  322  Human Services to pose a threat to the public health.
  323         (7)DISTRIBUTION REQUIREMENTS.—Eligible Canadian suppliers
  324  and importers participating under the program:
  325         (a)Must comply with the tracking and tracing requirements
  326  of 21 U.S.C. ss. 360eee et seq.
  327         (b)May not distribute, dispense, or sell drugs imported
  328  under the program outside of the program or outside of this
  329  state.
  330         (8)PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.—
  331         (a)The vendor shall ensure the safety and quality of drugs
  332  imported under the program. The vendor shall:
  333         1.For an initial imported shipment, ensure that each batch
  334  of the drug in the shipment is statistically sampled and tested
  335  for authenticity and degradation in a manner consistent with the
  336  Federal Act.
  337         2.For any subsequent imported shipment, ensure that a
  338  statistically valid sample of the shipment was tested for
  339  authenticity and degradation in a manner consistent with the
  340  Federal Act.
  341         3.Certify that the drug:
  342         a.Is approved for marketing in the United States and is
  343  not adulterated or misbranded; and
  344         b.Meets all of the labeling requirements under 21 U.S.C.
  345  s. 352.
  346         4.Maintain qualified laboratory records, including
  347  complete data derived from all tests necessary to ensure that
  348  the drug is in compliance with the requirements of this section.
  349         5.Maintain documentation demonstrating that the testing
  350  required by this section was conducted at a qualified laboratory
  351  in accordance with the Federal Act and any other applicable
  352  federal and state laws and regulations governing laboratory
  353  qualifications.
  354         (b)All testing required by this section must be conducted
  355  in a qualified laboratory that meets the standards under the
  356  Federal Act and any other applicable federal and state laws and
  357  regulations governing laboratory qualifications for drug
  358  testing.
  359         (c)The vendor shall maintain information and documentation
  360  submitted under this section for a period of at least 7 years.
  361         (d)A participating importer must submit the all of
  362  following information to the vendor:
  363         1.The name and quantity of the active ingredient of the
  364  drug.
  365         2.A description of the dosage form of the drug.
  366         3.The date on which the drug is received.
  367         4.The quantity of the drug that is received.
  368         5.The point of origin and destination of the drug.
  369         6.The price paid by the importer for the drug.
  370         (e)A participating Canadian supplier must submit the
  371  following information and documentation to the vendor specifying
  372  all of the following:
  373         1.The original source of the drug, including:
  374         a. The name of the manufacturer of the drug.
  375         b. The date on which the drug was manufactured.
  376         c. The location (country, state or province, and city)
  377  where the drug was manufactured.
  378         2.The date on which the drug is shipped.
  379         3.The quantity of the drug which is shipped.
  380         4.The quantity of each lot of the drug originally received
  381  and from which source.
  382         5.The lot or control number and the batch number assigned
  383  to the drug by the manufacturer.
  384         (f)The agency may require that the vendor collect any
  385  other information necessary to ensure the protection of the
  386  public health.
  387         (9)IMMEDIATE SUSPENSION.—The agency shall immediately
  388  suspend the importation of a specific drug or the importation of
  389  drugs by a specific importer if it discovers that any drug or
  390  activity is in violation of this section or any federal or state
  391  law or regulation. The agency may revoke the suspension if,
  392  after conducting an investigation, it determines that the public
  393  is adequately protected from counterfeit or unsafe drugs being
  394  imported into the state.
  395         (10)FEDERAL APPROVAL.—By July 1, 2020, the agency shall
  396  submit a request to the United States Secretary of Health and
  397  Human Services for approval of the program under 21 U.S.C. s.
  398  384(1). At a minimum, the request must do all of the following:
  399         (a)Describe the agency’s plan for operating the program.
  400         (b)Demonstrate how the drugs imported into the state under
  401  the program will meet the applicable federal and state standards
  402  for safety and effectiveness.
  403         (c) Demonstrate how the drugs imported into the state under
  404  the program will comply with federal tracing procedures.
  405         (d)Include a list of proposed drugs that have the highest
  406  potential for cost savings to the state through importation at
  407  the time that the request is submitted.
  408         (e)Estimate the total cost savings attributable to the
  409  program.
  410         (f) Provide the costs of program implementation to the
  411  state.
  412         (g)Include a list of potential Canadian suppliers from
  413  which the state would import drugs and demonstrate that the
  414  suppliers are in full compliance with relevant Canadian federal
  415  and provincial laws and regulations as well as all applicable
  416  federal and state laws and regulations.
  417         (11)NOTIFICATION OF FEDERAL APPROVAL.—Upon receipt of
  418  federal approval of the program, the agency shall notify the
  419  President of the Senate, the Speaker of the House of
  420  Representatives, and the relevant committees of the Senate and
  421  the House of Representatives. The program may not be implemented
  422  until the Legislature approves the program as authorized by the
  423  federal government. As part of its review process for
  424  implementation approval, the Legislature shall consider the
  425  estimated cost savings to the state and whether the program has
  426  met the required safety standards.
  427         (12)ANNUAL REPORT.—By December 1 of each year, the agency
  428  shall submit a report to the Governor, the President of the
  429  Senate, and the Speaker of the House of Representatives on the
  430  operation of the program during the previous fiscal year. The
  431  report must include, at a minimum:
  432         (a)A list of the drugs that were imported under the
  433  program;
  434         (b)The number of participating entities;
  435         (c)The number of prescriptions dispensed through the
  436  program;
  437         (d)The estimated cost savings during the previous fiscal
  438  year and to date in the program;
  439         (e)A description of the methodology used to determine
  440  which drugs should be included; and
  441         (f)Documentation of how the program ensures the following
  442  criteria:
  443         1.Canadian suppliers participating in the program are of
  444  high quality, high performance, and in full compliance with
  445  relevant Canadian federal and provincial laws and regulations as
  446  well as all United States and Florida laws and regulations;
  447         2.Drugs imported under the program are not shipped, sold,
  448  or dispensed outside of the state or the program once in the
  449  possession of the importer;
  450         3.Drugs imported under the program are unadulterated,
  451  potent, and safe;
  452         4.The program does not put consumers at a higher health
  453  and safety risk than if the consumer did not participate; and
  454         5.The program provides cost savings to the state.
  455         (13)RULEMAKING.—The agency may adopt rules necessary to
  456  implement this section.
  457         Section 2. This act shall take effect July 1, 2019.
  458  
  459  ================= T I T L E  A M E N D M E N T ================
  460  And the title is amended as follows:
  461         Delete everything before the enacting clause
  462  and insert:
  463                        A bill to be entitled                      
  464         An act relating to the Canadian Prescription Drug
  465         Importation Program; creating s. 381.02035, F.S.;
  466         requiring the Agency for Health Care Administration to
  467         establish the Canadian Prescription Drug Importation
  468         Program; defining terms; authorizing a Canadian
  469         supplier to export drugs into this state under the
  470         program under certain circumstances; providing
  471         eligibility criteria and requirements for drug
  472         importers; requiring the agency to contract with a
  473         vendor to facilitate wholesale prescription drug
  474         importation under the program; providing
  475         responsibilities for the vendor; providing eligibility
  476         criteria for prescription drugs, Canadian suppliers,
  477         and importers under the program; requiring
  478         participating Canadian suppliers and importers to
  479         comply with specified federal requirements for
  480         distributing prescription drugs imported under the
  481         program; prohibiting Canadian suppliers and importers
  482         from distributing, dispensing, or selling prescription
  483         drugs imported under the program outside the state;
  484         providing certain documentation requirements;
  485         requiring the agency to suspend the importation of
  486         drugs in violation of this section or any federal or
  487         state law or regulation; authorizing the agency to
  488         revoke the suspension under certain circumstances;
  489         requiring the agency to request federal approval of
  490         the program; requiring the request to include certain
  491         information; requiring the agency to begin operating
  492         the program within a specified timeframe after
  493         receiving federal approval; requiring the agency, in
  494         consultation with the vendor, to submit an annual
  495         report to the Governor and the Legislature by a
  496         specified date; providing requirements for such
  497         report; authorizing the agency to adopt rules;
  498         providing an effective date.