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State Boards and U.S. Food and Drug Administration Meeting Thursday, 12/19/12
On Thursday, 12/19/12, the FDA met with the state boards of pharmacy in a first-ever meeting between the groups. The purpose was for the FDA to obtain a greater understanding of pharmacy compounding. The following four topics were the subjects of the discussions from the groups:
- Given existing authorities and resources, are the states currently able to provide the needed oversight of pharmacy compounding and consumer protection?
- What should the federal role be in regulating higher risk pharmacy compounding such as compounding high volumes of drugs for interstate distribution?
- Is there a way to rebalance federal and state participation in the regulation of pharmacy compounding that would better protect the public health? What strategies should be developed to further strengthen federal/state communications?
- Do you see a role for the states in enforcing a federal standard for "non-traditional" compounding? If so, what role? What factors would affect a decision by your state to take on such a responsibility?
We will post the link to the recorded hearing when it becomes available.
U.S. Food and Drug Administration Chief Urges Action on Compounding
On Wednesday of this week, Dr. Margaret Hamburg urged state officials to help close regulatory loopholes involving the safety of compounded drugs. At a day-long meeting with officials from all 50 states, Hamburg called for new regulations to head off future public health disasters.
She said that health officials should have clear authority to monitor drug compounding operations and act before problems that endanger public safety erupt. We have experienced one of the biggest U.S. public health crises where 620 people in 19 states since mid-September have contracted fungal meningitis and thirty-nine patients have died.
The state health and pharmacy board officials are the latest group of stakeholders the FDA has approached with a plan the agency hopes Congress will turn into legislation. Previously, they have met with over 50 groups representing pharmacies, consumers, hospitals, clinics, and medical professionals. However, states could be most central to the questions about regulation because they currently serve as the main regulators of compounders.
http://www.reuters.com/article/2012/12/19/usa-health-meningitis-idUSL1E8NJ84N20121219
Branded Drug Revenues Drop 3.5% in 2012
Competition from generic drugs has hampered the performance of branded drugs with revenues forecast to fall at an average annual rate of 2.6% during the next few years, a new report forecasts; this decline will include a drop of 3.5% for this year.
The patent cliff which was first reached last year, when numerous patents on blockbuster drugs began to expire, has begun hurting industry revenues. Players in the industry have tried to adapt to expiring patents by investing more in biologic medicines since the Presidents ACA of 2010 introduced a method for the FDA to approve generic biologic drugs, but it also initiated a 12-year patent period on these types of products.
The brand-name pharmaceutical manufacturing industry in the U.S. is moderately concentrated with the top four players accounting for about half of the revenues. Merger and acquisition activity has been primarily driven by the escalating costs of research and development, shorter exclusivity times, and the need for global marketing power. Also, consolidation has been induced by changes to the pricing and other competitive strategies of pharmaceutical companies, including information technology, new U.S. federal legislation and the emergence of institutions, which include health maintenance organizations and pharmacy, benefit managers. To maintain profitability, the industry expects to continue consolidating and reducing costs, mainly through reductions in employment and research and development.
http://www.pharmatimes.com/Article/12-12-17/US_branded_drug_revenues_to_drop_3_5_in_2012.aspx
U.S. Food and Drug Administration Told There is No Need for Skin Preps to Be Sterile
Currently, antiseptic skin preparation products are not required to be sterile. The FDA was told this week by manufacturers, clinicians, and policy analysts that requiring sterility of antiseptic skin preparation products is unnecessary and wouldn't produce a dramatic drop in infections. Instead, the requirement would place an undue burden on companies. Some products that are used before surgery, before an injection, or to reduce the risk of skin infection have been recalled recently because of microbial contamination. Approximately 40 reports of contaminated antiseptic products have been submitted to the FDA.
http://www.medpagetoday.com/Washington-Watch/FDAGeneral/36448
Three Bronx Pharmacies Steal $7.7 Million from Medicaid
Sanjay Patel, owner of Bronx pharmacies, pleaded guilty to stealing $7.7 million from Medicaid by billing for drugs his patients never received. Sanjay K. Patel, 44, of Edison, New Jersey, is one of five pharmacy owners or supervising pharmacists who pleaded guilty over the past week to larceny charges before the Bronx Supreme Court. In all, the years-long probe uncovered fraud at seven Bronx pharmacies.
Patel was arrested November 15 along with his brother, Bharat Patel, 46, of Manhattan; Sanjay R. Patel, 47, of Edison; Divy Dixit, 43, of Edison; Alpesh Patel, 43, of Elmwood, New Jersey; for Medicaid thefts from 2003 to 2008 that totaled $9.9 million.
"These five pharmacists were caught red-handed, and they are being brought to justice," State Attorney General Eric Schneiderman said. "My office will track down those who steal from the public and continue to hold accountable those who use their positions as a vehicle to fleece New York's taxpayers."
http://www.nydailynews.com/new-york/bronx/druggists-plead-guilty-bilking-medicaid-article-1.1222847?localLinksEnabled=false
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