PHARMACY

PhRMA members to provide cost info in TV ads

BY Sandra Levy

Pharmaceutical Research and Manufacturers of America member companies’ direct-to-consumer television advertisements will soon direct patients to information about medicine costs, including the list price of the medicine, out-of-pocket costs, or other context about the potential cost of the medicine and available financial assistance.

Additionally, PhRMA said the biopharmaceutical industry also will launch a new platform that will provide patients, caregivers and providers with cost and financial assistance information for brand-name medicines, as well as other patient support resources.

“Our member companies are taking a new approach to how they communicate about medicines in DTC television advertisements to make it easier for patients to access information about medicine costs,” PhRMA president and CEO Stephen Ubl said. “The Administration and Congress have called on our industry to provide cost information in DTC advertisements, and our members are voluntarily stepping up to the plate.”

On Oct. 2, the PhRMA board of directors adopted enhancements to PhRMA’s voluntary DTC principles, Guiding Principles on Direct-to-Consumer Advertisements About Prescription Medicines — originally adopted in 2006.

The DTC principles have been expanded to include a new guiding principle stating, “All DTC television advertising that identifies a medicine by name should include direction as to where patients can find information about the cost of the medicine, such as a company-developed website, including the list price and average, estimated, or typical patient out-of-pocket costs, or other context about the potential cost of the medicine.”

The revised principles become effective on April 15, 2019, but changes to PhRMA members’ DTC television advertisements will begin in the coming months, the organization said.

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PHARMACY

FDA issues 2 guidances to advance development of new therapies

BY Sandra Levy

In an effort to modernize clinical trials and advance the development of safe and effective drugs and biologics, the Food and Drug Administration on Monday released two guidance documents to assist drug companies that are developing these next generation of therapies and treatments.

The FDA’s draft guidance entitled, “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment,” is aimed at sponsors planning to use minimal residual disease, or MRD, as a biomarker in clinical trials of drugs or biologics to treat specific blood cancers.

“MRD as a general measure of tumor burden has multiple potential regulatory and clinical uses as a biomarker to help with more informed drug development,” FDA commissioner Scott Gottlieb said in a statement. “Depending upon the clinical setting, MRD may reflect a patient’s response to treatment, or it may be used as a prognostic tool to assess the risk of future relapse.”

The FDA also issued a final guidance, “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease,” which was issued as draft guidance in December 2017. The guidance addresses the topic of finding treatments that address the underlying molecular changes, e.g., genetic variants, that often cause or contribute to diseases, including uncommon or rare molecular changes that are present in a small subset of patients.

“By providing clarity on the regulatory and scientific frameworks for product developers, safe and effective targeted treatments can be identified with scientifically valid tests and, ultimately, made available to patients more efficiently,” Gottlieb said.

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CVS Health reminds consumers to safely dispose unused medications

BY Sandra Levy

CVS Health is urging patients to clean out their medicine cabinets and safely dispose of unused prescription medication on National Prescription Drug Take Back Day on Oct. 27.

CVS Health has installed safe medication disposal units in more than 750 CVS Pharmacy locations nationwide and has donated more than 900 additional units to such community locations as police departments.

These units have collected more than 217 metric tons, or 480,000 pounds, of unwanted medication. Additionally, on Oct. 27, nearly 100 CVS Pharmacy locations will join other community sites around the country to host law enforcement take-back events, allowing the public to safely dispose of unwanted medication. National Prescription Drug Take Back Day is hosted biannually by the U.S. Drug Enforcement Administration, or DEA, to provide an opportunity for Americans to help prevent drug addiction and overdose deaths.

“CVS Health is dedicated to helping address and prevent prescription drug abuse and misuse, which is why we have worked to increase access to and awareness of safe medication disposal options in the communities we serve,” CVS Pharmacy vice president of professional services Tom Davis said in a statement. “Unused medications, especially opioids, should not be left in medicine cabinets where they could be at risk of misuse or diversion. We are proud to have supported the collection of more than 480,000 pounds of unwanted medication to date, getting it out of homes and disposed of safely, and we are looking forward to adding to that achievement.”

According to the 2016 National Survey on Drug Use and Health, 6.2 million Americans misused controlled prescriptions and often obtained them from family and friends. In-home medicine cabinets are often the source of diverted prescriptions, making it critical for patients to properly dispose of unused prescriptions in a timely manner to prevent prescription misuse and diversion.

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