prescription drug prices

On November 8, 2017, the Federal Trade Commission (FTC) will hold a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” Acting FTC Chairman Maureen K. Ohlhausen and U.S. Food and Drug Commissioner Dr. Scott Gottlieb will give the keynote addresses. Part of the goal of the workshop is to identify obstacles to competition and discuss policy steps that can increase the availability of generic drugs to consumers.

The Hatch-Waxman Act (the Act), which Congress passed over 30 years ago, provides a regulatory and judicial framework to expedite generic entry into U.S. prescription drug markets. For many drugs, the Act has helped reduce patent-related barriers to generic drug entry, which, in turn, has increased competition that has led to lower drug prices. In 2010, Congress created a similar framework for biosimilar drug development under the Biologics Price Competition and Innovation Act. Continue Reading Federal Trade Commission Announces Workshop on Competition in the Prescription Drug Market

The pharmacy industry is under increasing scrutiny from all angles. Whether at the legislative or agency level, Washington as well as many states seem intent on addressing perceived issues surrounding drug pricing, reimbursement, and program integrity.

In light of the significant changes in the pharmacy industry in 2015, Mintz Levin/ML Strategies is bringing together stakeholders and thought leaders from across the industry to share knowledge and insight on this rapidly shifting landscape at the 2016 Mintz Levin/ML Strategies Pharmacy Industry Summit.

The Summit will be on May 10 at the Mintz Levin Washington DC office. Event details can be found here.

Session topics will include:

  • State of the Industry – Drug Pricing Challenges and Opportunities
  • The New Wave of Value-Based Pricing and Contracting
  • The Repeal of Medicare Part D Non-Interference – Practical Realities
  • Federal and State Drug Transparency Initiatives
  • Implications of the Final AMP Rule

Space is limited so please register now.

 

 

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics.

In addition to covering a number of events related to the Affordable Care Act, telemedicine, and the nationwide opioid coverage crisis, this week’s Update covered the workshops held by the Food and Drug Administration (FDA) for genome scientists on the technical aspects of integrating Next-Generation Sequencing (NGS), a DNA-sequencing method, into clinical practice. Joanne Hawana, Eli Greenspan and Erin Kathleen Morton also published an alert on these workshops last week.

While the FDA has not yet developed a new regulatory framework for NGS that is different from the process for more traditional diagnostic tests, its goal is to institute “appropriate oversight, in a way that is more suitable to the complexity and data-richness of this new technology.” This focus on NGS is being driven by President Obama’s Precision Medicine Initiative, bipartisan and bicameral interest on Capitol Hill, and the desire of patients and physicians to be able to choose the right treatment, at the right time, with hopefully minimal side effects. A number of federal agencies have taken steps to implement the Precision Medicine Initiative, including the National Institutes of Health which seeks to enroll one million volunteers in the next five years in a study that will evaluate the risk of developing a disease by looking at both genetic and environmental factors. The FDA workshop last week was also in step with the President’s initiative. Continue Reading ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments