Cummings and Sanders Seek Information About Possible Obstruction of a Congressional Investigation on Generic Drug Prices
On August 14, Rep. Elijah E. Cummings (D-MD), the Chairman of the House Committee on Oversight and Reform, and Sen. Bernie Sanders (I-VT), Ranking Member of the Senate Budget Committee, sent letters to Heritage Pharmaceuticals, Mylan N.V., and Teva Pharmaceutical Industries, Ltd. renewing a 2014 document request about the companies’ pricing of generic drugs. Cummings and Sanders also requested information regarding the companies’ apparent efforts to stonewall the 2014 investigation, in order to obtain a more detailed understanding of what specific actions took place to impede efforts, thwart the ability of Congress to enact legislative reform, and jeopardize patients access to generic drugs.


Grassley Urges HHS, FDA to Implement Unannounced Inspections of Foreign Drug Manufacturing Facilities
On Aug. 6, Senate Finance Committee Chairman Chuck Grassley (R-IA) sent a letter to Department of Health and Human Services (HHS) Secretary Alex Azar, and Food and Drug Administration (FDA) Acting Commissioner Norman Sharpless urging them to reinstate unannounced inspections of prescription drug manufacturing facilities in foreign countries.  The reason for the request is the Trump administration’s new “Safe Importation Action Plan” as well as the fact that these facilities provide most of the ingredients for production inside the United States.

Grassley Asks Novartis For Information on Zolgensma
Senate Finance Committee Chair Chuck Grassley (R-IA) sent a letter to Novartis AG requesting information by Aug. 23 regarding the manufacturer’s knowledge of data manipulation during the approval process for its $2.1 million gene therapy Zolgensma.

Blackburn Introduces Three Bills on Rural Health
On Aug. 1, Sen. Marsha Blackburn (R-TN) introduced a rural health package that includes three bills. The first bill, the Rural America Health Corps Act is cosponsored by Sens. Durbin, Kevin Cramer (R-ND), Doug Jones (D-AL) and Lisa Murkowski (R-AK). It gives a two-year forgiveness period for the existing National Health Services Corp, which provides $50,000 a year to repay student loans for primary care doctors, behavioral health clinics, nurse practitioners and physician assistants who serve in “health professional shortage areas.”

The second bill, the Rural Health Innovations Act, co-sponsored by Murkowski, authorizes the Health Resources and Services Administration’s Community-Based Division to create two five-year grant programs. The first grant program allows existing federally qualified health centers (FQHCs) and rural health clinics (RHC), as well as start-up clinics, to expand their services to be able to triage and stabilize patients in emergencies, including increasing the availability of lab and x-ray equipment. The bill grants $500,000 for existing facilities and $750,000 for start-up facilities.

The third bill, the Telemedicine Across State Lines Act, instructs the HHS to write a rule on best practices for providing telehealth across state lines with input from stakeholders. Regular reports to Congress on the HHS’ progress would be required.

Read more on healthcare policy on the McGuireWoods Consulting website.