Generics Companies, Senators Praise CREATES Act

Senate Judiciary Committee members and generics makers in June both sung the praises of a bill aimed at preventing branded drugmakers from restricting access to their products.

The bill is aimed at companies that restrict access to samples, thereby preventing generics companies from reverse-engineering a product, or requesting a distribution safety protocol and then blocking generics companies from participating. It would give generic drug manufacturers a way to seek injunctive relief against a branded competitor that engages in these delaying tactics.

Innovator drug companies came under fire during the subcommittee hearing, with both senators and generic drugmakers accusing them of using the FDA-mandated REMS process to block generic competition.

Beth Zelnick-Kaufman, assistant general counsel at generics maker Amneal Pharmaceuticals, said the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act “provides necessary remedies” when innovators refuse to provide samples of their product.

REMS Abuses

Zelnick-Kaufman cited an example of her company attempting to join a brand REMS with an unidentified drugmaker to launch a product designed to treat drug addiction. She said the brand made $1 billion as a result of delay tactics. The unnamed company’s effort to block generic access ended only after the FDA issued its first waiver of the REMS requirement, she said.

Robin Feldman, a professor at the University of California Hastings College of the Law, also applauded the bill. She cited a study she is currently conducting which has found the increase of REMS abuse to be “abundantly clear.” She said the result has cost billions of dollars in savings in recent years.

Only one of the six panelists demonstrated some degree of opposition to the bill. Peter Safir of the law firm Covington & Burling expressed concerns over the consistency of the CREATES Act with the language of the FD&C Act.

Safir notes that the FD&C Act includes several civil and criminal penalties that can be brought against drugmakers for violating a single REMS requirement, saying the CREATES Act fails to amend the FD&C Act to protect innovators. He says this can confuse the brand name drugmakers and expose them to enforcement.

Industry Concerns

Peter Pitts, president and founder of the Center for Medicine in the Public Interest and a former FDA associate commissioner, also expressed some reservations about the bill. He told Generic Line that the bill significantly overreaches what it wants to accomplish, which could result in unintended consequences to patient safety.

Pitts also described the bill as a “get out of jail free card” for generics makers.

PhRMA spokeswoman Holly Campbell told Generic Line that the drug lobby is currently reviewing the legislation, but that it would be concerned if it jeopardizes patient safety in regards to REMS.

The CREATES Act was introduced in June by members of the Senate Judiciary Committee, including Chairman Sen. Chuck Grassley (R-Iowa), ranking member Patrick Leahy (D-Vt.), Sen. Amy Klobuchar (D-Minn.) and Sen. Mike Lee (R-Utah).

The Generic Pharmaceutical Association praised the legislation, writing in a letter to the senators that the bill “would provide a clear solution to abusive, anticompetitive business practices that increase costs to the American healthcare system by impeding patient access to generic medicines.”

The Senate Judiciary Committee did not return a request for comment by press time as to whether a date for a vote has been set. — Michael Cipriano


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