Tag Archives: Trade

  • Consolidation Activity in the Generic Sector

    … developed to assume that products will remain available to consumers at the right price. As producers drop out, monopolies are developed and the Federal Trade Commission is obliged to step in to protect competition and consumer choice.  This involves its own level of management which can also put stress on the company to deliver products to the consumer. So beneath the economic/business surface news of an acquisition/there’s the underlying practical considerations which may be overlooked …

  • The Smart Road to Pharmaceutical Consulting

    … development, managed markets, medical affairs, sales, and Trade and distribution. On the other hand, Maxim Group has more of an IT slant, and offers services such as IT strategic roadmap, IT utilization/value assessment, software package selection, software package implementation, and system integration. Then there are the pharmaceutical consulting firms, such as Smart Consulting Group, that fall somewhere in the middle, with their own niche areas of specialization owing to specific training and …

  • The Role of Interim Monitors in Divestitures

    … associated with mergers in highly regulated and complex industries, the Federal Trade Commission (FTC) has the power to include special provisions in a Consent Order to appoint an individual, known as an interim monitor, to oversee the operation.  The FTC regards the interim monitor as the eyes and ears of the FTC and is required to watch all of areas of the merger or acquisition and identify any issues that may arise which may hinder an independent and effective competitor from being …

  • Retirement of Mickey Flynn

    … the Board of Directors and a member of the Executive Committee.  Molineaux will continue in his role as senior vice president for membership services and begin over the next five months to transition into broader operational responsibilities of the association. Flynn is a founder of Pennsylvania Bio, the Trade association for the bioscience industry in Pennsylvania, and served as a Board member and chairman before assuming the role of president of the association in November 2005. “Mickey …

  • AAI, CONSUMER GROUPS ENCOURAGE CONGRESS TO BAN PATENT SETTLEMENTS AND RESTORE COMPETITION IN MARKET FOR GENERIC DRUGS

    … payments in pharmaceutical patent settlements in the final health reform legislation that both the House and Senate will consider soon. During the past decade, some branded and generic pharmaceutical firms have entered into settlements in which the branded firm pays the generic firm not to enter the market.  These arrangements, known as exclusion payments or pay-for-delay settlements, can significantly impede the entry of generic drugs.  The Federal Trade Commission estimates that these …

  • Patient Safety Resides in Global Thinking

    … globalization of the pharma Trade.  Manufacturers, distributors, re-packagers, and retailers may be all located in different countries or even continents.  Given the complexity of the supply process, drugs have become a profitable target for illegal distribution and forgery. Many methods have been proposed to protect patients, however, the answer may be very simple: an approach in phases, which initially focuses on the point of dispensing and avoids the significant difficulties and costs that …

  • India, Strong Pharma Destination

    … are settled.  India is compliant with the Trade Related Intellectual Property Rights Act (TRIPS).  It holds a first-class data-processing infrastructure for biostatistics and bioinformatics, and huge generic drug-manufacturing facilities. All of these are critical aspects for R&D costs, which have dramatically been increasing for the past few years.  It is vital to streamline the development process as much as possible.  Even though there are no language barriers, US pharma-related …

  • FTC Releases Report on “Follow-on Biologic Drug Competition”

    Below is the press release report released today following up on a workshop held in November 2008. Access to report and press release are available at http://www.ftc.gov/opa/2009/06/biologics.shtm. FTC Releases Report on “Follow-on Biologic Drug Competition” Providing FDA With Authority to Approve Follow-on Biologics Would be an Efficient Way to Bring Them to Market, Lowering Consumers’ Health Care Costs The Federal Trade Commission today released a report entitled “Follow-on Biologic …

  • Lean Alone Is Not Enough

    … because of the amount of materials coming from overseas, some of them of lesser quality than the domestic ones. Still, others have had to increase materials inventories because of unreliable delivery services. Due to this situation, manufacturers are implementing ideas that are compatible with the lean thinking, like Trade payables, allowing them to order extra materials while keeping low inventories. However, it seems these ideas are not being implemented fast enough; they are, in reality, …

  • Case Study: Divestiture of a Prescription Generic Pharmaceutical Pursuant to an Federal Trade Commission Consent Order

    An acquisition of a generic pharmaceutical company by a larger generic company (Respondent) resulted in a Federal Trade Commission Consent Order that required the divestiture of a prescription pharmaceutical product to a third party acquirer. The responsibility of Smart Consulting Group (SCG) was to act as the Interim Monitor for the divestiture to review and evaluate the Respondent: (1) the transfer of product and technology, the transfer of the business and marketing information, and (3) the …