Life Science Compliance Update

August 01, 2016

PhRMA and BIO Release Drug Maker Communication Guidelines


On Wednesday, July 27, 2016, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) released guidelines for drug makers’ communications with other health care professionals about their products.

The guidelines encompassed nine principles aimed at improving relationships between biopharmaceutical companies and other players in the health care industry, calling on the Food and Drug Administration (FDA) to clarify what information biopharmaceutical companies can share in addition to approved labels. The principles focused on three main areas, commitment to: science-based communications, providing appropriate context about data, and accurately representing data.

According to the guidelines,

"To exercise sound medical judgment in treating patients, health care professionals must understand the full range of treatment options, including both established and emerging information about available medications. Biopharmaceutical companies are uniquely positioned to help health care professionals achieve the best outcomes for patients, because companies can provide timely, accurate, and comprehensive information about both approved and unapproved uses of the medications they research, develop, and bring to patients. PhRMA, BIO, and their members believe that the availability of a wider range of truthful and non-misleading information can help health care professionals and payers make better informed medical decisions for their patients, which in turn will benefit patients."

The principles are as follows:

  1. Commitment to Accurate, Science-Based Communications
  2. FDA-Approved Labeling is a Primary Source in Sharing Information with Health Care Professionals About Medicines
  3. Companies Should Provide Scientific Substantiation if Shared Information is Not Contained in FDA-Approved Labeling
  4. Additional Science-based Information from Sources Other Than FDA-Approved Labeling Helps Health Care Professionals and Payers Make Informed Decisions for Patients
  5. Communications Should Be Tailored to the Sophistication of the Intended Audience
  6. Science-based Information About Alternative Uses of Medicines Can Improve Health Care Decision-Making
  7. Communicating with Payers About New Medicines and New Uses of Approved Medicines Facilitates Patient Access Upon Approval
  8. Real-World Evidence Based on Patient Experience and Pharmacoeconomic Information Can Improve Understanding of Health Outcomes and Costs
  9. Commitment to Share Information Published in Scientific or Medical Journals

The principles report from PhRMA and BIO goes on to illuminate how the responsible sharing of information, including the following categories, can improve patient care and the efficiency of the health care system:

  • Data from randomized, controlled clinical trials that evaluate pre-specified endpoints under a clearly defined analysis plan.
  • Post hoc analyses, including sub-population data. Randomized controlled clinical trials and observational studies often collect information on the safety and effectiveness of medicines in subpopulations, including specific gender and ethnic cohorts. If the trial has met its primary endpoint, subpopulation information may help health care professionals develop treatment strategies based on more precise safety and efficacy data for a particular cohort of patients.
  • Observational data and real world evidence, which can help clinicians understand how medicines perform across a diverse patient population outside of controlled trials. Such data may reflect prescribing patterns in different clinical practice settings, alternative doses, and differing durations of treatment, as well as comparisons between two or more therapies.
  • Pharmacoeconomic information.

Insurers and drug companies agree that further dialogue between them could help address the high costs of specialty drugs, but the current limited safe harbors are preventing those discussions happening. Perhaps these principles will help to push these communications into the realm of reality.

November 26, 2012

Clinical Practice Guidelines and the IOM Recommendations: Not There Yet

We there yet
Clinical practice guidelines have significantly grown over the last few decades, and more than 2,500 now can be found in the archives of the Agency for Healthcare Research and Quality’s (AHRQ) National Guideline Clearinghouse.  “However, concerns have been raised about the reliability of many of these guidelines and the processes involved in their development. 

To address these concerns, the Institute of Medicine (IOM) issued a new set of standards for clinical practice guidelines in March 2011 intended to enhance the quality of guidelines being produced.  In promulgating these standards, IOM focused on eight areas: 

1.    Establishing transparency

2.    Management of conflict of interest (COI)

3.    Guideline development group composition

4.    Clinical practice guideline–systematic review intersection

5.    Establishing evidence foundations for and rating strength of recommendations

6.    Articulation of recommendations

7.    External review; and

8.    Updating

Despite these new standards, a recent study published in the Archives of Internal Medicine, noted that no systematic review of adherence to such standards had been undertaken since one published over a decade ago.  As a result, two reviewers independently screened 130 guidelines selected at random from the National Guideline Clearinghouse (NGC) website for compliance with 18 of 25 IOM standards. 

The study found that “Clinical practice guidelines are falling far short of their mandate from the Institute of Medicine (IOM) that they be transparent and objective, as well as untainted by conflicts of interest, researchers reported,” reported MedPage Today.   

Specifically, they identified inadequate information on conflicts of interest, which was provided for committee members in less than half of guidelines examined.  Moreover, of those guidelines including such information, COIs were present in over two-thirds of committee chairpersons (71.4%) and 90.5% of co-chairpersons.  Guidelines from non-U.S. groups and medical specialty societies were the most unlikely to include this information. 

The median number of IOM standards met by a random sample of 114 sets of guidelines was eight out of 18 (44.4%), and fewer than half of the guidelines adhered to at least 50% of the standards, according to Philip A. Mackowiak, MD, of the University of Maryland in Baltimore, and colleagues.   

“Subspecialty societies were the worst in this regard, with barely a third of their guidelines satisfying more than 50% of the IOM standards surveyed.”  The noted the failure of guidelines from specialty societies to provide conflict-of-interest information, the investigators noted.

“Less than a third of guidelines prepared under the aegis of subspecialty organizations -- whose recommendations carry added weight because of their special expertise and whose members stand to profit directly from such recommendations -- included information on [conflicts of interest],” the researchers argued. 

“Everybody everywhere is developing guidelines and there is no real quality control,” Dr. Mackowiak, told Reuters.  “There is no good oversight of who actually develops the guidelines or what criteria need to be met in order for them to be published.” 

Other important shortcomings were a lack of information on the process by which committee members are chosen, and non-inclusion of patient representatives or information scientists.  “Of the specific areas in which clinical practice guidelines need to be improved, none is more pressing than that having to do with the composition of committees developing the guidelines,” the researchers stated. 

In addition, benefits of treatment were more often emphasized than potential harms, and were only presented as generalizations.  A further shortcoming was that differences of opinion on the published evidence were seldom presented. "Guidelines were nearly always written in such a way as to suggest that recommendations were unanimously supported by committee members," the researchers noted. 

A final concern was the age of many guidelines.  Some authors have suggested that guidelines should be updated every 5 years, yet fewer than half of those included in this review had been updated. 

One area in which the guidelines appeared more satisfactory was in gathering and organizing evidence, although abstracts and publications in languages other than English were rarely included. 

The researchers compared their findings with a similar report published in 1999, and concluded that “little, if any, progress has been made over the past quarter century in improving the quality of clinical practice guidelines.”  An even harsher assessment was made in an invited commentary by the author of the 1999 study, Terrence Shaneyfelt, MD, of the University of Alabama at Birmingham. 

“The same problems that have plagued guideline development continue to plague guideline development; namely, their variable and opaque development methods, their often conflicted and limited panel composition, and their lack of significant external review by stakeholders throughout the development process," Shaneyfelt stated. 

In his commentary, Shaneyfelt argued in favor of the centralization of guideline development, to avoid contradictory recommendations that can only make clinical practice more difficult.  He further stated that AHRQ should only publish guidelines that adhere to the IOM standards, but is “not optimistic.”  “I hope that efforts by the Guidelines International Network are successful, but until then, in guidelines we cannot trust,” Shaneyfelt concluded. 

The commentary and article fail to point out the value of guidelines and how their use has improved practice.   Often one gets caught in the weeds of an argument and misses the forest of good that guidelines have created.    No process will be perfect, the IOM has some very good ideas in their recommendations but finding experts who have not worked with the tools they are developing is not one of them.

June 13, 2012

Joint Commission to Require Hospitals to Provide Prevention and Wellness Promotion Services in 2013

Wellness Program

An article from FierceHealthcare noted how the Joint Commission recently issued new requirements for hospitals that provide health and wellness programs.  Institutions accredited or applying for accreditation in behavior healthcare must have a written plan, get input from the community and use evidence-based guidelines, effective Jan. 1, 2013.  The written plan must demonstrate how the organization provides prevention and wellness promotion services that are relevant to its mission and the scope of its services. 

An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.

Under the new rules, healthcare organizations must have staff who are trained or certified to deliver health and wellness services, although organizations may provide internal training. The Joint Commission also requires that healthcare organizations measure and review their wellness programs and make improvements when necessary.

The new rules come as more hospitals promote healthy living among their employees and patients by instituting no-smoking rules, enrolling workers into exercise programs or offering healthier cafeteria choices.  In addition to improving population health, such health and wellness services can give hospitals a competitive edge, experts said at the American College of Healthcare Executives' annual congress in March.

In addition to the requirements noted above, organizations that provide prevention and wellness promotion services must:

  • Seek input about the needs of the community served relative to prevention and wellness promotion services and use this information to guide its planning process.
  • Identify those resources within the community (if any) that will be utilized to support the provision of the organization’s prevention and wellness promotion services.
  • Determine whether evidence-based guidelines, promising or emerging practices, or expert consensus exists for the services it plans to provide. If such information does exist, the organization must determine whether it will use it to develop its services. 

The new measures also cover organizations who provide prevention and wellness promotion services that are managed.  The measures require: 

  • The organization provides prevention and wellness promotion services designed to meet the needs of an identified community.  Communities are identified according to various factors, such as age, sex, ethnicity, culture, and other defining traits.
  • For organizations that provide prevention and wellness promotion services: Staff who provide prevention and wellness promotion services are either trained or certified to provide such services. Training can be provided by the organization.
  • For organizations that provide prevention and wellness promotion services: When new prevention and wellness promotion services are begun, the organization establishes baseline demographics of the population(s) that will receive these services by gathering its own data or utilizing existing data.


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