Maine LD 1422: An Act To Allow Maine Residents To Personally Import Medications as Permitted under the Federal Food, Drug, and Cosmetic Act

LD 1422 (subjects: HEALTH CARE SERVICES , PRESCRIPTION DRUGS )

Official bill page at mainelegislature.org: http://www.mainelegislature.org/legis/bills/display_ps.asp?ld=1422&PID=1456&snum=127


Sponsors | Actions | Bill Text | Patterns of Support


Sponsors

Principal Sponsor: Rep. John L. Martin of Eagle Lake: (D – District 151) — e-mail

0 Cosponsors:

Actions

Chamber

Action
5/19/2015 House Committee on HEALTH AND HUMAN SERVICES suggested and ordered printed.
On motion of Representative McCABE of Skowhegan, TABLED pending REFERENCE.
Later today assigned.
5/19/2015 House Unfinished Business
5/20/2015 House Speaker laid before the House
Subsequently, the Bill was REFERRED to the Committee on LABOR, COMMERCE, RESEARCH AND ECONOMIC DEVELOPMENT.
Sent for concurrence. ORDERED SENT FORTHWITH.
5/21/2015 Senate On motion by Senator BRAKEY of Androscoggin Tabled until Later in Today’s Session, pending REFERENCE
Unfinished Business
5/26/2015 Senate Taken from the table by the President
On motion by Senator Volk of Cumberland REFERRED to the Committee on LABOR, COMMERCE, RESEARCH AND ECONOMIC DEVELOPMENT , in concurrence.
6/9/2015 House Reports READ.
On motion of Representative HERBIG of Belfast, the Minority Ought to Pass Report was ACCEPTED.
ROLL CALL NO. 190
(Yeas 85 – Nays 62 – Absent 4 – Excused 0)
The Bill was READ ONCE.
Under suspension of the rules, the Bill was given its SECOND READING without REFERENCE to the Committee on Bills in the Second Reading.
The Bill was PASSED TO BE ENGROSSED.
HELD at the Request of Representative McCABE of Skowhegan.
6/10/2015 House RELEASED.

Sent for concurrence. ORDERED SENT FORTHWITH.
6/11/2015 Senate Reports READ.
Senator VOLK of Cumberland moved to ACCEPT the Majority Ought Not to Pass Report, in NON-CONCURRENCE.
On further motion by same Senator, TABLED until Later in Today’s Session, pending her motion to ACCEPT the Majority Ought Not to Pass Report, in NON-CONCURRENCE.
Unfinished Business
6/12/2015 Senate Unfinished Business
6/15/2015 Senate Unfinished Business
6/17/2015 Senate Unfinished Business
6/17/2015 Senate Taken from the table by the President ProTem
Subsequently, On motion by Senator VOLK of Cumberland The Majority Ought Not To Pass Report ACCEPTED , in NON-CONCURRENCE.
Roll Call Ordered Roll Call # 280 22 Yeas – 13 Nays- 0 Excused – 0 Absent PREVAILED
Ordered sent down forthwith for concurrence.
6/17/2015 House The House INSISTED on ACCEPTANCE of the Minority Ought to Pass Report and PASSAGE TO BE ENGROSSED.
ORDERED SENT FORTHWITH.
6/18/2015 Senate Motion by Senator VOLK of Cumberland The Senate INSISTED To ACCEPTANCE of the Majority OUGHT NOT TO PASS Report , in non-concurrence.
Placed in Legislative Files (DEAD).

Bill Text

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An Act To Allow Maine Residents To Personally Import Medications as Permitted under the Federal Food, Drug, and Cosmetic Act

Emergency preamble. Whereas, acts and resolves of the Legislature do not become effective until 90 days after adjournment unless enacted as emergencies; and

Whereas, Maine residents benefitted until recently from a Maine law that allowed importation of prescription drugs from pharmacies in other countries; and

Whereas, a federal court ruled that the Maine law was in violation of federal law, a ruling that could cause many residents, including senior citizens and low-income residents, to forgo their medication because it is too costly; and

Whereas, this legislation, based on federal guidance regarding the personal importation of prescription drugs, allows the importation of certain prescription drugs from certain countries; and

Whereas, this legislation needs to take effect as soon as possible to provide some relief to those Maine residents who can no longer afford their prescription drugs; and

Whereas, in the judgment of the Legislature, these facts create an emergency within the meaning of the Constitution of Maine and require the following legislation as immediately necessary for the preservation of the public peace, health and safety; now, therefore,

Be it enacted by the People of the State of Maine as follows:

Sec. 1. 22 MRSA c. 603-A is enacted to read:

CHAPTER 603-A

MAINE PHARMACEUTICAL DRUG SAFETY ACT

2699-A. Short title

This chapter may be known and cited as “the Maine Pharmaceutical Drug Safety Act.”

2699-B. Findings

The Legislature finds that allowing the citizens of Maine to import certain prescription drugs that are branded and registered in Canada and member countries of the European Union, but unapproved by the United States Food and Drug Administration in the Canadian or European branded or generic formula, will provide a level of safety to Maine consumers that they do not currently enjoy from unapproved foreign imports and the Food and Drug Administration personal importation policy.

2699-C. Personal importation policy

1. Definitions. As used in this chapter, unless the context otherwise indicates, the following terms have the following meanings.

A. “Member country” means Canada or a member country of the European Union. “Member country” does not include a country:

(1) In the European Union that was admitted into the European Union pursuant to the Treaty of Accession 2003 to which a transitional measure for the regulation of human pharmaceutical products applies and has expired;

(2) That the United States Secretary of State determines will not meet the requirements for the regulation of human pharmaceutical products by the date on which a transitional measure for the regulation of human pharmaceutical products expires;

(3) That the United States Secretary of State confirms to the Attorney General has failed to:

(a) Authorize the approval of those drugs that have been determined to be safe and effective by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs on the basis of adequate and well-controlled investigations, including clinical investigations;

(b) Require the methods used in and the facilities and controls used for the manufacture, processing and packaging of drugs in that country to be adequate to preserve the drugs’ identity, quality, purity and strength;

(c) Undertake the reporting of adverse reactions to drugs and procedures to withdraw approval and remove drugs found not to be safe or effective;

(d) Require the labeling and promotion of a drug to be in accordance with the approval of the drug;

(e) Adequately train pharmacists;

(f) Adequately regulate the practice of pharmacy; or

(g) Adequately protect the privacy of personal medical information; or

(4) From which the importation of drugs to the United States will adversely affect public health as determined by the United States Secretary of State.

B. “Pharmacist” means a person licensed by a member country to practice in a pharmacy, including the dispensing and selling of prescription drugs.
C. “Pharmacy” means a business licensed by a member country to engage in the selling of prescription drugs at retail that employs 50 or more licensed pharmacists.
D. “Prescription drug” means any drug required to be reported to a state prescription monitoring program and includes but is not limited to substances listed in the federal Controlled Substances Act and unapproved new drugs.
E. “Unapproved new drug” means any drug, including a foreign-made version of a prescription drug, that has not been manufactured in accordance with and pursuant to the United States Food and Drug Administration approval.

2. Importation of prescription drugs. An individual may import only for the use of that individual or a member of that individual’s immediate family a prescription drug from a pharmacy in a member country that is allowed to export prescription drugs under that member country’s regulations.
3. Prohibitions on importation of prescription drugs. The following actions are prohibited.

A. An individual may not import a prescription drug about which the United States Food and Drug Administration has issued a public notice stating that the prescription drug:

(1) Lacks evidence of effectiveness;

(2) Is a health fraud drug product;

(3) Presents a direct challenge to the United States Food and Drug Administration’s new drug application and over-the-counter monograph processes; or

(4) Has been reformulated by the manufacturer or exporter to evade an existing United States Food and Drug Administration enforcement action.

B. An individual may not reimport a drug approved by the United States Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act that was originally manufactured in the United States.
C. An individual may not import a controlled substance. As used in this paragraph, “controlled substance” has the same meaning as in Section 802 of the federal Controlled Substances Act.
D. An individual may not import a prescription drug for sale or resale.

An individual who violates this subsection commits a Class D crime.

4. Rules. The department shall adopt routine technical rules under Title 5, chapter 375, subchapter 2-A to implement the provisions of this chapter.

Emergency clause. In view of the emergency cited in the preamble, this legislation takes effect when approved.

summary

Under the Federal Food, Drug, and Cosmetic Act, the importation of unapproved new prescription drugs, including foreign-made versions of prescription drugs that have been approved by the federal Food and Drug Administration, is prohibited. However, the Food and Drug Administration has developed guidance that allows the personal importation of certain drugs.

This bill, using the guidance developed by the Food and Drug Administration, enacts the Maine Pharmaceutical Drug Safety Act to allow an individual in Maine to import prescription drugs from Canada or certain member countries of the European Union for use by that individual or a member of that individual’s immediate family. The country from which the prescription drug is to be imported must meet specific criteria regarding regulation of its pharmacies and pharmacists, as determined by the United States Secretary of State. The prescription drug to be imported must also meet specific requirements. The importation of controlled substances and prescription drugs for sale or resale is specifically prohibited.

Patterns of Support

Pattern of Cosponsorship by Region:

Pattern of Cosponsorship by Gender:

Pattern of Cosponsorship by Party:

Pattern of Cosponsorship by Campaign Finance Classification:

Note: Maine Clean Elections Act (MCEA) Qualified candidates only accept a small dollar value of initial contributions early in their campaigns, pledge not to accept further campaign contributions from private sources, and receive public funding for their campaigns. MCEA Non-Qualified candidates choose not to obtain public funding and instead are free to accept campaign contributions from individuals, party committees, political action committees and business sources.


This information about LD 1422 was last updated on 2016-05-12.
The Open Maine Politics website is in a beta release and results should not be taken as definitive. Please visit the official website of the Maine State Legislature for entirely verifiable information.

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