HARRY HUGHES, Governor

1889

(2) AFTER PROVIDING AN OPPORTUNITY FOR A PUBLIC
HEARING AND JUDICIAL APPEAL, THE SECRETARY MAY REVOKE AN
APPLICATION THAT WAS APPROVED UNDER THIS SECTION IF, BASED
ON EVIDENCE THAT IS ACQUIRED AFTER APPROVAL, THE SECRETARY
FINDS THAT:

(I)  THE DRUG MAY NOT BE SAFE FOR OR
EFFECTIVE IN ITS INTENDED USE; OR

(II)  THE FACILITIES OR CONTROLS USED IN
THE MANUFACTURE, PROCESSING, OR LABELING OF THE DRUG MAY
PRESENT A HAZARD TO THE PUBLIC HEALTH.

(H) RECORDS AND REPORTS.

IN ACCORDANCE WITH ANY RULE OR REGULATION THAT IS
ADOPTED OR ANY ORDER THAT IS ISSUED BY THE SECRETARY UNDER
THIS SECTION, THE PERSON WHO HOLDS AN APPLICATION FOR A DRUG
THAT IS APPROVED UNDER THIS SECTION SHALL:

(1)  KEEP RECORDS; AND

(2)  SUBMIT REPORTS TO THE SECRETARY.

(I) RULES, REGULATIONS, AND ORDERS ABOUT RECORDS AND
REPORTS.

(1)  THE SECRETARY MAY ADOPT RULES AND
REGULATIONS THAT APPLY GENERALLY TO PERSONS WHOSE
APPLICATIONS FOR DRUGS HAVE BEEN APPROVED OR, AS TO A
PARTICULAR PERSON WHOSE APPLICATION HAS BEEN APPROVED, ISSUE
AN ORDER THAT REQUIRES AN APPLICANT:

(I)  TO KEEP RECORDS OF INFORMATION THAT
RELATES TO CLINICAL EXPERIENCE WITH THE DRUG AND ANY OTHER
INFORMATION THAT THE APPLICANT OBTAINS ABOUT THE DRUG; AND

(II)  TO SUBMIT REPORTS TO THE SECRETARY
CONCERNING THAT INFORMATION.

(2)  WHEN ADOPTING A RULE OR REGULATION OR
ISSUING AN ORDER THAT REQUIRES THE SUBMISSION OF INFORMATION
UNDER THIS SUBSECTION, THE SECRETARY SHALL CONSIDER THE
PROFESSIONAL ETHICS OF THE MEDICAL PROFESSION AND THE
INTERESTS OF PATIENTS.

(3)  ANY RULE, REGULATION, OR ORDER UNDER THIS
SECTION SHALL PROVIDE THAT IF ANY PERSON TO WHOM THE RULE,
REGULATION, OR ORDER APPLIES REQUESTS IT, AND IF THE
SECRETARY CONSIDERS IT TO BE APPROPRIATE, THE PERSON MAY
EXAMINE SIMILAR INFORMATION THAT IS OBTAINED BY THE
SECRETARY CONCERNING THE DRUG.