Florida Senate - 2019                             CS for SB 1528
       
       
        
       By the Committee on Health Policy; and Senators Bean and Gruters
       
       
       
       
       
       588-03459-19                                          20191528c1
    1                        A bill to be entitled                      
    2         An act relating to the Canadian Prescription Drug
    3         Importation Program; creating s. 381.02035, F.S.;
    4         requiring the Agency for Health Care Administration to
    5         establish the Canadian Prescription Drug Importation
    6         Program; defining terms; authorizing a Canadian
    7         supplier to export drugs into this state under the
    8         program under certain circumstances; providing
    9         eligibility criteria and requirements for drug
   10         importers; requiring the agency to contract with a
   11         vendor to facilitate wholesale prescription drug
   12         importation under the program; providing
   13         responsibilities for the vendor; providing eligibility
   14         criteria for prescription drugs, Canadian suppliers,
   15         and importers under the program; requiring
   16         participating Canadian suppliers and importers to
   17         comply with specified federal requirements for
   18         distributing prescription drugs imported under the
   19         program; prohibiting Canadian suppliers and importers
   20         from distributing, dispensing, or selling prescription
   21         drugs imported under the program outside the state;
   22         providing certain documentation requirements;
   23         requiring the agency to suspend the importation of
   24         drugs in violation of this section or any federal or
   25         state law or regulation; authorizing the agency to
   26         revoke the suspension under certain circumstances;
   27         requiring the agency to request federal approval of
   28         the program; requiring the request to include certain
   29         information; requiring the agency to begin operating
   30         the program within a specified timeframe after
   31         receiving federal approval; requiring the agency, in
   32         consultation with the vendor, to submit an annual
   33         report to the Governor and the Legislature by a
   34         specified date; providing requirements for such
   35         report; authorizing the agency to adopt rules;
   36         providing an effective date.
   37          
   38  Be It Enacted by the Legislature of the State of Florida:
   39  
   40         Section 1. Section 381.02035, Florida Statutes, is created
   41  to read:
   42         381.02035 Canadian Prescription Drug Importation Program.—
   43         (1)PROGRAM ESTABLISHED.—The Agency for Health Care
   44  Administration shall establish a program for the importation of
   45  safe and effective prescription drugs from Canada which have the
   46  highest potential for cost savings to the state.
   47         (2) DEFINITIONS.—As used in this section, the term:
   48         (a)“Agency” means the Agency for Health Care
   49  Administration.
   50         (b)“Canadian supplier” means a manufacturer, wholesale
   51  distributor, or pharmacy appropriately licensed or permitted
   52  under Canadian law to manufacture, distribute, or dispense
   53  prescription drugs.
   54         (c)“Drug” or “prescription drug” has the same meaning as
   55  “prescription drug” in s. 499.003.
   56         (d)“Federal Act” means the Federal Food, Drug, and
   57  Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
   58  as amended by the Drug Quality and Security Act, 21 U.S.C. 351
   59  et seq.
   60         (e)“Importer” means a wholesale distributor, pharmacy, or
   61  pharmacist importing prescription drugs into this state under
   62  the program.
   63         (f)“Pharmacist” means a person who holds an active and
   64  unencumbered license to practice pharmacy pursuant to chapter
   65  465.
   66         (g)“Program” means the Canadian Prescription Drug
   67  Importation Program.
   68         (h) “Track-and-trace” means the product-tracing process for
   69  the components of the pharmaceutical distribution supply chain
   70  as described in Title II of the Drug Quality and Security Act,
   71  Drug Supply Chain Security Act, 21 U.S.C. 351 et seq.
   72         (i)“Vendor” means the entity contracted by the agency to
   73  manage specified functions of the program.
   74         (3)ELIGIBLE CANADIAN SUPPLIERS.—A Canadian supplier may
   75  export drugs into this state under the program if the supplier
   76  meets all of the following requirements:
   77         (a)Complies fully with relevant Canadian federal and
   78  provincial laws and regulations.
   79         (b)Complies fully with the Federal Act, including all
   80  other state and federal law and regulations relating to the
   81  track-and-trace requirements at the package level.
   82         (c)Submits evidence at time of contract award and
   83  throughout the contract term of a surety bond or comparable
   84  security arrangement from this state or any other state in the
   85  United States in the minimum amount of $1 million. The agency
   86  shall reevaluate and adjust the amount of the bond annually,
   87  based on program volume. The surety bond or comparable security
   88  arrangement must include the State of Florida as a beneficiary.
   89  In lieu of the surety bond, the supplier may provide a
   90  comparable security arrangement such as an irrevocable letter of
   91  credit or a deposit into a trust account or financial
   92  institution which includes the State of Florida as a
   93  beneficiary. The purposes of the bond or other security
   94  arrangements for the program are to:
   95         1.Ensure payment of any administrative penalties imposed
   96  by the agency or any other state agency under the contract when
   97  the supplier fails to pay within 30 days after assessment;
   98         2.Ensure performance of contractual and statutory
   99  obligations by the supplier through use of a bond or other
  100  comparable security arrangements to receive payment of any other
  101  costs or fees incurred by the agency, the state, or other
  102  entities acting on behalf of the state if the supplier is non
  103  compliant with its contractual and statutory obligations. If the
  104  supplier is assessed a penalty under the program and fails to
  105  pay within 30 days after that assessment, the agency, the state,
  106  or an entity acting on behalf of the state may file a claim for
  107  reimbursement against the bond or other comparable security
  108  arrangement; and
  109         3.Allow for claims to be made against the bond or other
  110  comparable security arrangements for up to 1 year after the
  111  supplier’s contract under the program has ended with the agency
  112  or the state, the supplier’s license is no longer valid, or the
  113  program has ended, whichever occurs last.
  114  
  115  A surety bond or other comparable security arrangement is
  116  required regardless of the time of bid or negotiation process
  117  used by the agency or the type of final contract or agreement
  118  executed for services.
  119         (d)Is identified by the vendor as eligible to participate
  120  in the program.
  121         (e) Submits evidence at the time of contract award and
  122  throughout the contract term of a surety bond or comparable
  123  security arrangement from this state or any other state in the
  124  United States in the minimum amount of $1 million. The agency
  125  shall reevaluate and adjust the amount of the bond annually,
  126  based on program volume. The surety bond or comparable security
  127  arrangement must include the State of Florida as a beneficiary.
  128  In lieu of the surety bond, the supplier may provide a
  129  comparable security arrangement such as an irrevocable letter of
  130  credit or a deposit into a trust account or financial
  131  institution which includes the State of Florida as a
  132  beneficiary. The purposes of the bond or other security
  133  arrangements for the program are to:
  134         1.Indemnify the supplier in the event that any civil or
  135  criminal legal action is brought by the state, the agency, any
  136  other state agency, or private individuals or entities against
  137  the supplier because of the supplier’s failure to perform under
  138  the contract, including, but not limited to, causes of actions
  139  for personal injury, negligence, and wrongful death;
  140         2.Ensure payment by the supplier of legal judgements and
  141  claims that have been awarded to the state, the agency, other
  142  entities acting on behalf of the state, individuals, or
  143  organizations if the supplier is assessed a final judgement or
  144  other monetary penalty in a court of law for a civil or criminal
  145  action related to participation in the program. The bond or
  146  comparable security arrangement may be accessed if the supplier
  147  fails to pay any judgement or claim within 60 days after final
  148  judgement; and
  149         3.Allow for civil and criminal litigation claims to be
  150  made against the bond or other comparable security arrangements
  151  for up to 1 year after the supplier’s contract under the program
  152  has ended with the agency or the state, the supplier’s license
  153  is no longer valid, or the program has ended, whichever occurs
  154  last.
  155         (4)ELIGIBLE IMPORTERS.—
  156         (a)The following entities or persons may import
  157  prescription drugs from a Canadian supplier under the program:
  158         1.A wholesale distributor.
  159         2.A pharmacy.
  160         3.A pharmacist.
  161         (b)An eligible importer must meet all of the following
  162  requirements at time of contract award and throughout the
  163  contract term:
  164         1.Register with the vendor before importing drugs into the
  165  state under the program and be deemed in compliance with all
  166  requirements, including any relevant provisions of the Federal
  167  Act.
  168         2.Submit evidence at time of contract award and throughout
  169  the contract term of a surety bond or other comparable security
  170  arrangement from this state or any other state in the United
  171  States in the amount of $1 million. The surety bond or
  172  comparable security arrangement must include the State of
  173  Florida as a beneficiary. In lieu of the surety bond, the
  174  supplier may provide a comparable security agreement such as an
  175  irrevocable letter of credit or a deposit into a trust account
  176  or financial institution which includes the State of Florida as
  177  a beneficiary, payable to the State of Florida. The purposes of
  178  the bond or other security arrangements for the program are to:
  179         a.Ensure payment of any administrative penalties imposed
  180  by the agency or any other state agency under the contract when
  181  the importer fails to pay within 30 days after assessment;
  182         b.Ensure performance of contractual and statutory
  183  obligations by the importer through use of a bond or other
  184  comparable security arrangements to receive payment of any other
  185  costs or fees incurred by the agency, the state, or other
  186  entities acting on behalf of the state if the importer is non
  187  compliant with its contractual and statutory obligations. If the
  188  importer is assessed a penalty under the program and fails to
  189  pay within 30 days after that assessment, the agency, the state,
  190  or an entity acting on behalf of the state may file a claim for
  191  reimbursement against the bond or other comparable security
  192  arrangement; and
  193         c.Allow for claims to be made against the bond or other
  194  comparable security arrangements for up to 1 year after the
  195  importer’s contract under the program has ended with the agency
  196  or the state, the importer’s license is no longer valid, or the
  197  program has ended, whichever occurs last.
  198  
  199  A surety bond or comparable document is required regardless of
  200  the time of bid or negotiation process used by the agency or the
  201  type of final contract or agreement executed for services.
  202         (c) Submits evidence at the time of contract award and
  203  throughout the contract term of a surety bond or comparable
  204  security arrangement from this state or any other state in the
  205  United States in the minimum amount of $1 million. The agency
  206  shall reevaluate and adjust the amount of the bond annually,
  207  based on program volume. The surety bond or comparable security
  208  arrangement must include the State of Florida as a beneficiary.
  209  In lieu of the surety bond, the supplier may provide a
  210  comparable security agreement such as an irrevocable letter of
  211  credit or a deposit into a trust account or financial
  212  institution which includes the State of Florida as a
  213  beneficiary, payable to the State of Florida. The purposes of
  214  the bond or other security arrangements for the program are to:
  215         1.Ensure participation of the supplier in any civil or
  216  criminal legal action by the state, the agency, any other state
  217  agency, or private individuals or entities against the supplier
  218  because of the supplier’s failure to perform under the contract,
  219  including, but not limited to causes of actions for personal
  220  injury, negligence, and wrongful death;
  221         2.Ensure payment by the supplier through the use of a bond
  222  or other comparable security arrangements of legal judgements
  223  and claims that have been awarded to the agency, the state,
  224  other entities acting on behalf of the state, individuals, or
  225  organizations if the supplier is assessed a final judgement or
  226  other monetary penalty in a court of law for a civil or criminal
  227  action under the program. The bond or comparable security
  228  arrangement will be accessed if the supplier fails to pay any
  229  judgement or claim within 60 days after final judgement; and
  230         3.Allow for civil and criminal litigation claims to be
  231  made against the bond or other comparable security arrangements
  232  for up to 1 year after the supplier’s contract under the program
  233  has ended with the agency or the state, the supplier’s license
  234  is no longer valid, or the program has ended, whichever occurs
  235  last.
  236         (5)IMPORTATION PROCESS.—
  237         (a)The agency shall contract with a vendor to provide
  238  services under the program. The vendor must submit evidence of a
  239  surety bond with any bid or initial contract negotiation
  240  documents and maintain documentation of evidence of such a bond
  241  with the agency throughout the contract term of a surety bond
  242  from this state or any other state in the United States in the
  243  same amount of $1 million. The surety bond or comparable
  244  security arrangement must include the State of Florida as a
  245  beneficiary. In lieu of the surety bond, the supplier may
  246  provide a comparable security agreement such as an irrevocable
  247  letter of credit or a deposit into a trust account or financial
  248  institution which includes the State of Florida as a
  249  beneficiary, payable to the State of Florida. The purposes of
  250  the bond or other security arrangements for the program are to:
  251         1.Ensure payment of any administrative penalties imposed
  252  by the agency or any other state agency under the contract when
  253  the vendor fails to pay within 30 days after assessment;
  254         2.Ensure performance of contractual and statutory
  255  obligations by the vendor through use of a surety bond or other
  256  comparable security arrangements to receive payment of any other
  257  costs or fees incurred by the agency, the state, or other
  258  entities acting on behalf of the state if the vendor is non
  259  compliant with its contractual and statutory obligations. If the
  260  vendor is assessed a penalty under the program and fails to pay
  261  within 30 days after that assessment, the agency, the state, or
  262  an entity acting on behalf of the state may file a claim for
  263  reimbursement against the bond or other comparable security
  264  arrangement; and
  265         3.Allow for claims to be made against the bond or other
  266  comparable security arrangements for up to 1 year after the
  267  vendor’s contract under the program has ended with the agency or
  268  the state, the importer’s license is no longer valid, or the
  269  program has ended, whichever occurs last.
  270  
  271  A surety bond or comparable document is required regardless of
  272  the time of bid or negotiation process used by the agency or the
  273  type of final contract or agreement executed for services.
  274         (b)Submits evidence at the time of contract award and
  275  throughout the contract term of a surety bond or comparable
  276  security arrangement from this state or any other state in the
  277  United States in the minimum amount of $1 million. The agency
  278  shall reevaluate and adjust the amount of the bond annually,
  279  based on program volume. The surety bond or comparable security
  280  arrangement must include the State of Florida as a beneficiary.
  281  In lieu of the surety bond, the supplier may provide a
  282  comparable security arrangement such as an irrevocable letter of
  283  credit or a deposit into a trust account or financial
  284  institution which names the State of Florida as a beneficiary.
  285  The purposes of the bond or other security arrangements for the
  286  program are to:
  287         1.Ensure participation of the vendor in any civil or
  288  criminal legal action by the state, the agency, any other state
  289  agency, or private individuals or entities against the vendor
  290  because of the vendor’s failure to perform under the contract,
  291  including, but not limited to causes of actions for personal
  292  injury, negligence, and wrongful death;
  293         2.Ensure payment by the vendor through the use of a bond
  294  or other comparable security arrangements of legal judgements
  295  and claims that have been awarded to the agency, the state,
  296  other entities acting on behalf of the state, individuals, or
  297  organizations if the vendor is assessed a final judgement or
  298  other monetary penalty in a court of law for a civil or criminal
  299  action under the program. The bond or comparable security
  300  arrangement will be accessed if the vendor fails to pay any
  301  judgement or claim within 60 days after final judgement; and
  302         3.Allow for civil and criminal litigation claims to be
  303  made against the bond or other comparable security arrangements
  304  for up to 1 year after the vendor’s contract under the program
  305  has ended with the agency or the state, the vendor’s license is
  306  no longer valid, or the program has ended, whichever occurs
  307  last.
  308         (c)The vendor shall provide all of the following services
  309  at a minimum:
  310         1.Develop a list every 3 month of drugs that have the
  311  highest potential for cost savings to the state if imported from
  312  Canada. In developing the list, the vendor shall consider, at a
  313  minimum, which drugs will provide the greatest cost savings to
  314  the state, including drugs for which there are shortages,
  315  specialty drugs, and high-volume drugs. The agency may direct
  316  the vendor to revise the list, as necessary.
  317         2.Identify Canadian suppliers that are in full compliance
  318  with relevant Canadian federal and provincial laws and
  319  regulations and the Federal Act and who have agreed to export
  320  drugs identified on the list. The vendor must verify that such
  321  Canadian suppliers meet all of the requirements of the program
  322  and will export drugs at prices that will provide cost savings
  323  to the state while meeting or exceeding the track-and-trace
  324  federal and state laws and regulations.
  325         3.Contract with such eligible Canadian suppliers, or
  326  facilitate contracts between eligible importers and Canadian
  327  suppliers, to import drugs under the program.
  328         4.Maintain a listing of all registered importers that
  329  participate in the program.
  330         5.Ensure compliance with Title II of the federal Drug
  331  Quality and Security Act P.L. 113-54 by all suppliers, importers
  332  and other distributors and participants in the program.
  333         6.Assist the agency with the annual report as required in
  334  subsection (12) and provide any information requested by the
  335  agency for such report on a timely basis.
  336         (d)The profit margin and administrative fees of any
  337  participating wholesaler, pharmacy, or pharmacist on imported
  338  drug products is limited to a maximum amount as specified
  339  annually in the General Appropriations Act.
  340         (6)ELIGIBLE PRESCRIPTION DRUGS.—Eligible importers may
  341  import a drug from an eligible Canadian supplier if:
  342         (a)The drug meets the United States Food and Drug
  343  Administration’s standards related to safety, effectiveness,
  344  misbranding, and adulteration;
  345         (b)Importing the drug would not violate the patent laws of
  346  the United States;
  347         (c)Importing the drug is expected to generate cost
  348  savings; and
  349         (d)The drug is not:
  350         1.A controlled substance as defined in 21 U.S.C. s. 802;
  351         2.A biological product as defined in 42 U.S.C. s. 262;
  352         3.An infused drug;
  353         4.An intravenously injected drug;
  354         5.A drug that is inhaled during surgery; or
  355         6.A drug that is a parenteral drug, the importation of
  356  which is determined by the United States Secretary of Health and
  357  Human Services to pose a threat to the public health.
  358         (7)DISTRIBUTION REQUIREMENTS.—Eligible Canadian suppliers
  359  and importers participating under the program:
  360         (a)Must comply with the tracking and tracing requirements
  361  of 21 U.S.C. ss. 360eee et seq.
  362         (b)May not distribute, dispense, or sell drugs imported
  363  under the program outside of the program or outside of this
  364  state.
  365         (8)PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.—
  366         (a)The vendor shall ensure the safety and quality of drugs
  367  imported under the program. The vendor shall:
  368         1.For an initial imported shipment, ensure that each batch
  369  of the drug in the shipment is statistically sampled and tested
  370  for authenticity and degradation in a manner consistent with the
  371  Federal Act.
  372         2.For any subsequent imported shipment, ensure that a
  373  statistically valid sample of the shipment was tested for
  374  authenticity and degradation in a manner consistent with the
  375  Federal Act.
  376         3.Certify that the drug:
  377         a.Is approved for marketing in the United States and is
  378  not adulterated or misbranded; and
  379         b.Meets all of the labeling requirements under 21 U.S.C.
  380  s. 352.
  381         4.Maintain qualified laboratory records, including
  382  complete data derived from all tests necessary to ensure that
  383  the drug is in compliance with the requirements of this section.
  384         5.Maintain documentation demonstrating that the testing
  385  required by this section was conducted at a qualified laboratory
  386  in accordance with the Federal Act and any other applicable
  387  federal and state laws and regulations governing laboratory
  388  qualifications.
  389         (b)All testing required by this section must be conducted
  390  in a qualified laboratory that meets the standards under the
  391  Federal Act and any other applicable federal and state laws and
  392  regulations governing laboratory qualifications for drug
  393  testing.
  394         (c)The vendor shall maintain information and documentation
  395  submitted under this section for a period of at least 7 years.
  396         (d)A participating importer must submit the all of
  397  following information to the vendor:
  398         1.The name and quantity of the active ingredient of the
  399  drug.
  400         2.A description of the dosage form of the drug.
  401         3.The date on which the drug is received.
  402         4.The quantity of the drug that is received.
  403         5.The point of origin and destination of the drug.
  404         6.The price paid by the importer for the drug.
  405         (e)A participating Canadian supplier must submit the
  406  following information and documentation to the vendor specifying
  407  all of the following:
  408         1.The original source of the drug, including:
  409         a. The name of the manufacturer of the drug.
  410         b. The date on which the drug was manufactured.
  411         c. The location (country, state or province, and city)
  412  where the drug was manufactured.
  413         2.The date on which the drug is shipped.
  414         3.The quantity of the drug which is shipped.
  415         4.The quantity of each lot of the drug originally received
  416  and from which source.
  417         5.The lot or control number and the batch number assigned
  418  to the drug by the manufacturer.
  419         (f)The agency may require that the vendor collect any
  420  other information necessary to ensure the protection of the
  421  public health.
  422         (9)IMMEDIATE SUSPENSION.—The agency shall immediately
  423  suspend the importation of a specific drug or the importation of
  424  drugs by a specific importer if it discovers that any drug or
  425  activity is in violation of this section or any federal or state
  426  law or regulation. The agency may revoke the suspension if,
  427  after conducting an investigation, it determines that the public
  428  is adequately protected from counterfeit or unsafe drugs being
  429  imported into the state.
  430         (10)FEDERAL APPROVAL.—By July 1, 2020, the agency shall
  431  submit a request to the United States Secretary of Health and
  432  Human Services for approval of the program under 21 U.S.C. s.
  433  384(l). At a minimum, the request must do all of the following:
  434         (a)Describe the agency’s plan for operating the program.
  435         (b)Demonstrate how the drugs imported into the state under
  436  the program will meet the applicable federal and state standards
  437  for safety and effectiveness.
  438         (c) Demonstrate how the drugs imported into the state under
  439  the program will comply with federal tracing procedures.
  440         (d)Include a list of proposed drugs that have the highest
  441  potential for cost savings to the state through importation at
  442  the time that the request is submitted.
  443         (e)Estimate the total cost savings attributable to the
  444  program.
  445         (f) Provide the costs of program implementation to the
  446  state.
  447         (g)Include a list of potential Canadian suppliers from
  448  which the state would import drugs and demonstrate that the
  449  suppliers are in full compliance with relevant Canadian federal
  450  and provincial laws and regulations as well as all applicable
  451  federal and state laws and regulations.
  452         (11)NOTIFICATION OF FEDERAL APPROVAL.—Upon receipt of
  453  federal approval of the program, the agency shall notify the
  454  President of the Senate, the Speaker of the House of
  455  Representatives, and the relevant committees of the Senate and
  456  the House of Representatives. The program may not be implemented
  457  until the Legislature approves the program as authorized by the
  458  federal government. As part of its review process for
  459  implementation approval, the Legislature shall consider the
  460  estimated cost savings to the state and whether the program has
  461  met the required safety standards.
  462         (12)ANNUAL REPORT.—By December 1 of each year, the agency
  463  shall submit a report to the Governor, the President of the
  464  Senate, and the Speaker of the House of Representatives on the
  465  operation of the program during the previous fiscal year. The
  466  report must include, at a minimum:
  467         (a)A list of the drugs that were imported under the
  468  program;
  469         (b)The number of participating entities;
  470         (c)The number of prescriptions dispensed through the
  471  program;
  472         (d)The estimated cost savings during the previous fiscal
  473  year and to date in the program;
  474         (e)A description of the methodology used to determine
  475  which drugs should be included; and
  476         (f)Documentation of how the program ensures the following
  477  criteria:
  478         1.Canadian suppliers participating in the program are of
  479  high quality, high performance, and in full compliance with
  480  relevant Canadian federal and provincial laws and regulations as
  481  well as all United States and Florida laws and regulations;
  482         2.Drugs imported under the program are not shipped, sold,
  483  or dispensed outside of the state or the program once in the
  484  possession of the importer;
  485         3.Drugs imported under the program are unadulterated,
  486  potent, and safe;
  487         4.The program does not put consumers at a higher health
  488  and safety risk than if the consumer did not participate; and
  489         5.The program provides cost savings to the state.
  490         (13)RULEMAKING.—The agency may adopt rules necessary to
  491  implement this section.
  492         Section 2. This act shall take effect July 1, 2019.