Tucked into a recently proposed rule on when the FDA will regulate products derived from tobacco as a drug, device or combination therapy is a broader provision lopping off part of the agency’s “intended use” regulations that lay out the criteria for when a product falls under the FDA’s regulatory eye or may be deemed misbranded.

Under the proposal, the agency would no longer consider the manufacturer’s knowledge as a basis for intended use. In actuality, the change simply puts current practice into policy, but it still removes a potential misbranding threat for sponsors who know their products are being used off-label, said Susan Lee, a senior associate with Hogan Lovells.

It also suggests the FDA is rethinking its intended use rules amid an “increasing drumroll of challenge” to its authority in restraining commercial speech, Lee told BioWorld Today.

For years, drug- and device-makers have demanded more clarity on the agency’s intended use policies, especially where they intersect with a doctor’s legal off-label use of a regulated product and sponsors’ constitutional speech rights. Those demands have grown since courts in the Second Circuit started ruling in favor of drugmakers opposing the FDA’s restraints.

“There’s a lot of impatience, especially in light of the court decisions that have come out consistently that the FDA is out of line” with the Constitution, Lee said, referring specifically to the recent Amarin decision in which a federal district judge proceeded to give the agency a crash course on the meaning of the Second Circuit’s Caronia ruling, which has been hailed as a solid victory for commercial speech.

“Penalizing truthful statements promoting an off-label use ‘paternalistically interferes with the ability of physicians and patients to receive potentially relevant treatment information,’” the judge told the FDA, quoting from the appellate court’s decision in U.S. v. Caronia. Judge Paul Engelmayer added that if the agency disagreed with the Caronia ruling, it should have appealed it rather than trying to re-interpret it. (See BioWorld Today, Aug. 11, 2015.)

In the wake of the court decisions, industry wants FDA policies to conform more closely with the principles of constitutionally protected commercial speech, Lee said. It also wants guidance and regulations giving sponsors greater latitude to discuss off-label uses with doctors, distribute scientific articles and have freer conversations, in general, with health care providers.

In response to industry demands, the FDA has promised further guidance and public meetings, Lee said. But so far, it hasn’t delivered on those promises.

By proposing the changes to the intended use regs, the agency is opening the door for industry comment on the rule and its impact on protected speech. Lee advised drug- and device-makers to seize the opportunity and demand further clarification.

Getting new rules recognizing the role of commercial speech would be the best option, she said. While guidance would be helpful, it’s not enforceable, and judicial relief generally only helps one company at a time, she noted.

Comments on the proposed rule, which was released last month, are due by Nov. 24.

BASS IPR ACCEPTED

Fueling the likelihood of more drug and device inter partes review (IPR) challenges for the sake of stock manipulation, the Patent and Trademark Appeals Board (PTAB) granted review this week of an IPR petition filed by hedge fund manager Kyle Bass and his Coalition for Affordable Drugs (CFAD).

The petition challenges four claims in the single patent listed in the FDA’s Orange Book for Dublin-based Shire plc’s ulcerative colitis drug Lialda (mesalamine). The patent, which expires in June 2020, also is being challenged in court by a number of generic drugmakers.

Shire had fought the IPR, saying the petition failed to list all real parties-in-interest because it didn’t name individual investors or CFAD’s sister companies. But PTAB found insufficient evidence that sister companies or unnamed investors paid for expenses associated with the petition or controlled or participated in the filing of the petition – links necessary to qualify them as a real party-in-interest.

Although CFAD has filed dozens of IPR petitions on drug patents, this is the first to be instituted by PTAB. However, Bass has reportedly profited from investors’ reaction to news of the various challenges. PTAB now has one year to rule on the validity of the Lialda patent based on prior art. (See BioWorld Today, Aug. 26, 2015.)

VALEANT HIT WITH SUBPOENAS

The pile-on continues for Valeant Pharmaceuticals International Inc., of Laval, Quebec, as it finds itself responding to repeated government inquiries about its drug pricing.

The latest came in the form of two subpoenas from U.S. attorney offices in Massachusetts and southern New York. The company said it’s reviewing the subpoenas – which seek information about drug pricing, patient assistance programs and distribution practices – and intends to cooperate with the investigations.

Valeant responded Wednesday to a letter from Sen. Claire McCaskill (D-Mo.) regarding price hikes for heart drugs Isuprel (isoproterenol) and Nitropress (nitroprusside) after Valeant acquired them from Marathon Pharmaceuticals earlier this year. In its response, the company said it is beginning to reach out to hospitals where the impact of the price increase was “significantly greater than the average.”

The Canadian company got sucked into the maelstrom kicked up by Turing Pharmaceuticals LLC last month after New York-based Turing hiked the price on a newly acquired drug by nearly 5,500 percent. Expanding their investigation into Turing’s acquire-and-hike pricing model, several members of the House Committee on Oversight and Government Reform sought a subpoena compelling Valeant to turn over documents relating to price increases for its two heart drugs. (See BioWorld Today, Sept. 30, 2015.)

The pressure is taking a toll on the company, with shares (NYSE:VRX) losing $8.42 Thursday, to close at $168.87. Just before the investigations began last month, Valeant was trading at more than $240.

FDA TO PREPARE FOR FUTURE BIOTECH

The FDA, along with other federal agencies, will hold a public meeting Oct. 30 to discuss the president’s July memorandum on modernizing the regulatory system for biotech products.

The memo directs the FDA, Environmental Protection Agency and U.S. Department of Agriculture to update the government’s 1992 coordinated framework for regulating biotechnology to clarify their current regulatory roles and responsibilities in the space, the FDA said in a notice slated for publication in Friday’s Federal Register.

The memo also tasks the agencies with developing a long-term strategy to ensure the regulatory system is ready for future biotech products and with commissioning an independent, expert analysis of the biotech landscape to come.

NIH proposes research guideline changes

The NIH is proposing amendments to its guidelines for research involving recombinant or synthetic nucleic acid.

The changes would affect the criteria and process for selecting protocols for review by the agency’s Recombinant DNA Advisory Committee and streamline the process by which human gene transfer protocols are registered with the NIH, according to a notice to be published in Friday’s Federal Register.

Comments on the proposal are due by Nov. 30.