Drugs

OIG Refining Patient Assistance Program Rules: Attorney

Attorney Chelsea Rutherford (McDermott Will & Emery) says that the HHS Inspector General has been issuing advisory opinions that revise its approach to patient assistance programs (PAPs) that provide financial assistance or free prescription drugs to low-income individuals. “While none of these opinions or modifications are dramatically new on their face,” she says in an online blog post, “together they provide valuable insight into the types of facts that can mitigate the OIG’s general concerns with tailored disease funds.”

Historically, Rutherford explains, the OIG has been more comfortable with true charitable programs that are not drug-specific and that reflect other characteristics demonstrating a broad patient focus, rather than those reflecting a drug or pharmaceutical manufacturer focus.

Because of a trend of some independent charity PAPs establishing or operating specific disease funds that limit assistance to a subset of available products, the OIG in 2014 articulated a concern with such PAPs and said it would view them as having a higher baseline risk of abuse when their assistance was limited to only a subset of available FDA-approved products for treatment of the disease.

New opinions and modifications in 2015, Rutherford writes, are consistent with the standard but add nuanced factors and exceptions that appear to show a more refined stance on specific disease funds.

“While the OIG continues to reiterate the potential risks posed by disease funds that are tailored to specific symptoms, severity of symptoms, method of drug administration, stages of a disease, or types of drug treatment,” she concludes, “its recent opinions and modifications illustrate several exceptions to this general position.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome