Section 6004

SEC. 6004. PRESCRIPTION DRUG SAMPLE TRANSPARENCY.

Part A of title XI of the Social Security Act [42 U.S.C. 1301 et seq.], as amended by section 6002, is amended by inserting after section 1128G the following new section:

'SEC. 1128H. REPORTING OF INFORMATION RELATING TO DRUG SAMPLES.

'[a] In General- Not later than April 1 of each year [beginning with 2012], each manufacturer and authorized distributor of record of an applicable drug shall submit to the Secretary [in a form and manner specified by the Secretary] the following information with respect to the preceding year:

'[1] In the case of a manufacturer or authorized distributor of record which makes distributions by mail or common carrier under subsection [d][2] of section 503 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353], the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by--

'[A] the name, address, professional designation, and signature of the practitioner making the request under subparagraph [A][i] of such subsection, or of any individual who makes or signs for the request on behalf of the practitioner; and

'[B] any other category of information determined appropriate by the Secretary.

'[2] In the case of a manufacturer or authorized distributor of record which makes distributions by means other than mail or common carrier under subsection [d][3] of such section 503, the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by--

'[A] the name, address, professional designation, and signature of the practitioner making the request under subparagraph [A][i] of such subsection, or of any individual who makes or signs for the request on behalf of the practitioner; and

'[B] any other category of information determined appropriate by the Secretary.

'[b] Definitions- In this section:

'[1] APPLICABLE DRUG- The term 'applicable drug' means a drug--

'[A] which is subject to subsection [b] of such section 503; and

'[B] for which payment is available under title XVIII or a State plan under title XIX or XXI [or a waiver of such a plan].

'[2] AUTHORIZED DISTRIBUTOR OF RECORD- The term 'authorized distributor of record' has the meaning given that term in subsection [e][3][A] of such section.

'[3] MANUFACTURER- The term 'manufacturer' has the meaning given that term for purposes of subsection [d] of such section.'.