While patient engagement is firmly at the epicenter for health care initiatives and research efforts designed to speed the development of new cures, the American Medical Association (AMA) is reminding lawmakers that the physician voice also needs to be heard from ground zero.

"Physicians, along with patients, are at the forefront of a fundamental transformation in health care resulting from the intersection of genetic and genomic breakthroughs, the rapid growth of digital capabilities and the resultant new tools," the AMA said in a letter this week to Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.), the architects of the 21st Century Cures Initiative.

Leveraging the new tools requires a greater role for both physicians and patients in the modernization of regulatory oversight, coverage and payment flexibilities, and the development of a workable, interoperable data-sharing infrastructure, the group said.

So what do doctors, surgeons and other health care practitioners hope to come out of all the initiatives proposed by lawmakers and the administration?

An interoperable health information infrastructure tops the list of recommendations the physicians group submitted to Upton and DeGette for inclusion in the Cures legislation, which is now in a draft form for discussion. "The promise of 21st century cures is inextricably linked with the ability of physicians and patients to use technologies that support effective communication and that allow them to move information seamlessly through the health care continuum," the letter noted. (See BioWorld Today, Jan. 29, 2015.)

But the current lack of interoperability in electronic health records (EHRs) and registries could delay those cures, sideline the president's Precision Medicine Initiative and cripple efforts to enhance data sharing. (See BioWorld Today, Feb. 2, 2015.)

The AMA attributes the EHR interoperability problems to regulatory overreach that stifles innovation and negatively impacts the adoption of new technologies by adding numerous, overly complex measures that have nothing to do with data exchange. As a result, EHR systems are developed to meet regulatory requirements rather than physician and patient needs.

Also missing are semantic interoperability, syntactic interoperability and functional standards that are key to establishing consistency in data exchanges across platforms, the AMA said. For instance, standardized clinical data definitions and formats would improve the underlying data, providing necessary context.

Achieving true interoperability will require a collective effort from the medical community. Standardized "definitions should be developed through a consensus process that includes all specialties and practitioners . . . who understand the clinical context of the data elements based on the patients for whom care is provided," the AMA said.

Another physician concern is the overregulation of diagnostics. The AMA fears that the FDA's proposal to regulate laboratory-developed testing services would "choke off the primary development pipeline for new diagnostics, deny patients access to treatments and cures, and compromise the nation's public health capabilities, including diminishing our ability to detect and combat bio-threats and infectious disease outbreaks." The proposal also would regulate the practice of medicine, the AMA added. That's something the FDA isn't supposed to do.

However, a small subset of complex genetic/genomic tests that use proprietary, nontransparent algorithms should be subject to oversight to ensure their analytical and clinical validity, the group added. Going beyond that subset would interrupt clinical practice and require the FDA to divert its limited resources from developing a viable framework to address the regulatory challenges posed by next-generation sequencing, which would have implications for the Precision Medicine Initiative. (See BioWorld Insight, Jan. 26, 2015.)

Instead of its burdensome proposal to regulate all laboratory-developed testing, the AMA suggested the FDA modernize the Clinical Laboratory Improvement Amendments to mandate third-party accreditation of clinical laboratories. The FDA also should have "authority to regulate direct-to-consumer tests and testing services where incorrect results could cause harm to patients and the test methodology is not transparent nor well understood," the group said.

PCORI ADOPTS PEER REVIEW

Research sponsored by the Patient-Centered Outcomes Research Institute (PCORI) will be open to the public and subject to peer review through a process approved Tuesday by the institute's board of governors.

PCORI will require all studies to be registered with appropriate web-based registries, and results must be submitted to ClinicalTrials.gov within 12 months of the study being completed.

The peer review process, which will be based on the draft final reports grant recipients must submit summarizing their projects, will be overseen by PCORI, with input from subject matter experts, experts in research methodology or biostatistics, patients, caregivers and other health care stakeholders.

After responding to reviewers' comments, the researchers will work with PCORI to produce abstracts summarizing their results for medical professionals and the general public. The abstracts will be posted, within 90 days, on the PCORI website, along with anonymous reviewer comments, the awardee's responses, a link to the final results in ClinicalTrials.gov and other relevant information.

IMPORTANT LAW STRUCK DOWN

Citing preemption, a federal judge this week overturned a Maine law that permitted importation of prescription drugs from specified countries.

The law, which went into effect in October 2013, allowed Maine residents to import drugs for personal use from licensed retail pharmacies in Australia, Canada, New Zealand or the UK – if the pharmacies met their country's statutory and regulatory requirements. (See BioWorld Today, Oct. 11, 2013.)

The state's "singling out of certain countries from which pharmaceuticals may be imported compromises the tightly regulated structure" established by the Federal Food, Drug and Cosmetics Act, the judge ruled.

The legal challenge to the law was brought by Maine-based trade associations, individual pharmacists and the Pharmaceutical Research and Manufacturers of America. The national trade association, which was dismissed early on in the case for lack of standing, hailed the decision as a significant victory that confirms the role the FDA plays in regulating the U.S. drug supply chain and protecting consumers from counterfeit and adulterated drugs.

BILL EXPANDS R&D CREDIT

In the latest effort to expand the R&D tax credit used by many drug and device companies, Sens. Tom Carper (D-Del.) and Pat Toomey (R-Penn.) reintroduced the Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation (COMPETE) Act Tuesday.

The credit, first implemented in the early 1980s, expired for the eighth time last December. In addition to making it permanent, the COMPETE Act would strengthen the credit by increasing the rate to 25 percent of qualifying research investments. It also would remove administrative barriers and expand the reach of the credit to new sectors of the economy.

For instance, companies undertaking groundbreaking, contract-funded research projects in collaboration with other firms could claim a portion of the credit under the act, as could investors in small research companies.