The Senate’s tax plan, running counter to the House’s call to eliminate the orphan drug tax credit for research on drugs to treat rare diseases, seeks to modify the credit instead. The proposal would limit what level of expenses will qualify and limit qualified clinical expenses if they are related to the use of a drug which has previously been approved for diseases or conditions affecting more than 200,000 persons in the US. The tax credit is part of a law from...

The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay. Although none of the comments and arguments for reducing the price of pharmaceuticals were new, panelists and senators even seemed to disagree on what exactly is causing prices in the US to be so much higher than the rest of the world. Mark Merritt, president of the Phar...

The US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time on Wednesday and Thursday to give the agency input from  patients on clinical trials for medical devices. The meeting focused on a number of key issues related to clinical trials, with the goal of increasing patient input on trial design; patient recruitment, enrollment and retention; and communicating results back to patients. Patient Engagement at FDA FDA ...

The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change. The hearing discussed a bill that would seek to undercut FDA’s oversight of a program, known as expanded access, whereby terminally ill patients and their doctors can request access to an investigational drug outside of a clinical trial. Right-to-Try laws have now passed in 37 states...

This article provides insight for regulatory professionals regarding developing a successful advertising and promotional review of restricted medical devices. It demonstrates how medical device manufacturers and pharmaceutical companies can improve communication and collaboration between regulatory and marketing to streamline and improve the compliance review process for promotional materials and achieve an effective marketing strategy. The Dance "How small can I make...

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance from 2015 on advisory committee meetings. Background Other than the Medical Devices Dispute Resolution Panel (which this guidance does not address), there are 17 device panels: (1) Anesthesiology and Respiratory Therapy Devices; (2) Circulatory System Devices; (3) Clinical Chemistry and Clinical Toxicology Devices; (4) Dental Products; (5) E...

The Senate on Thursday passed via unanimous consent (meaning there was not actually a vote) a bill that claims to improve terminal patients' access to experimental drugs but, if passed in the House and signed into law, may further burden and undermine the US Food and Drug Administration (FDA). The bill is part of what's known as the "Right-to-Try" movement, which has been sweeping across state legislatures  (37 states now have such laws), and is part of a bid to in...

Experts speaking on behalf of a pharmaceutical company at US Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings often receive hefty sums, raising questions about the relationships between the companies and the experts ahead of three ODAC meetings next week. “We found that most (92.1%) expert speakers at FDA ODAC meetings receive sizable industry payments (median, $35,435). We were unable to establish payments made from the specific ...

The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down. Sen. Lamar Alexander (R-TN) opened the hearing by highlighting the extent to which biopharmaceutical companies pay for the development of new medicines, and to note there will be two more hearings focused on R&D and supply chain expenses, ...

The Senate Health, Education, Labor & Pensions (HELP) committee will hold a hearing Tuesday on prescription drug costs and look to address a problem many in America are grappling with: how the drug delivery system affects what patients pay. The hearing will likely address how pharmacy benefit managers (PBMs), insurers and others in the prescription drug ecosystem impact prices and what can be done to bring them down, though some are questioning whether anything subs...

Newly-confirmed US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday began to address what he deems to be his "highest initial priority," which is to "reduce the scope of the epidemic of opioid addiction." As a first step, Gottlieb announced the establishment of an Opioid Policy Steering Committee to bring together some of the agency’s senior career leaders to explore and develop tools or strategies to confront the crisis. The initial quest...

The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September. Two additional amendments were added to the latest version of the bill , one from Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) on expanded access to drugs and one from Sens...