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# OIG Asks PhRMA Companies for Free Drugs
- URL: https://www.fdaweb.com/oig-asks-phrma-companies-for-free-drugs/
- Published: 2018-01-05T12:00:00.000Z
- Updated: 2026-09-14T23:11:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140433

HHS Office of Inspector General (OIG) has asked Pharmaceutical and Research Manufacturers of America (PhRMA) for its help finding companies to provide free drugs to patients who were receiving assistance from a charitable group that fell out of favor with the government. A 1/14 [OIG letter](https://oig.hhs.gov/compliance/alerts/guidance/stansel-letter.pdf?ref=fdaweb.com) to PhRMA says the government will “not pursue administrative sanctions against any drug company for providing free drugs during 2018 to federal health care program beneficiaries who were receiving cost sharing support for those drugs from \[Caring Voice Coalition\] CVC.”

OIG says it rescinded a CVC-related advisory opinion late last year because CVC “failed to fully, completely, and accurately disclose all relevant and material facts to OIG. CVC's failure to comply with the certifications it made to OIG materially increased the risk that it served as a conduit for improper financial assistance from a drug company donor to a patient.”

With patients losing financial support from CVC, the letter continues, “(O)ne potential avenue for patients to receive such drugs is for a drug company to provide such drugs without charge to the patient or any federal health care program. In fact, OIG has previously issued advisory opinions approving of specific arrangements under which drug companies provide free drugs. Nevertheless, OIG has also noted that free drug programs that are not properly structured can implicate, and potentially violate, the federal anti-kickback statute. For example, free drug programs that provide assistance only during a portion of the Medicare Part D coverage year, such as only during the Medicare Part D coverage gap (i.e., ‘wrapping around’ the Part D benefit) pose a heightened risk of fraud and abuse because the Medicare Part D plans remain responsible for coverage before and after the coverage gap.”

The OIG letter also outlines safeguards for drug companies interested in providing free drugs.