Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

Susan Haigney

	Pharmaceutical Research and Manufacturers of America (PhRMA) International Vice-President Jay Taylor has expressed the organization’s concerns over the Office of the United States Trade Representative’s (USTR) 2013 Special 301 Report. The Special 301 Report, released in May 2013, is an annual review of the state of intellectual property (IP) rights protection and enforcement in trading partners around the world and reflects the US Administration’s resolve to maintain IP protection worldwide.

	Expressing appreciation for USTR’s efforts to ensure IP protection, Taylor expressed dismay that an out-of-cycle review was not granted for India. “The deteriorating protections for patented medicines in India have become increasingly concerning,” Taylor said in a PhRMA 

. “Over the past year, the Government of India has issued several intellectual property decisions that have disproportionately impacted US biopharmaceutical companies and a number of other innovative sectors. The IP regime in India has been structured and applied in ways that prop up local industries to the detriment of US jobs and the worlds patients.”

	According to the report, India remains on the Priority Watch List. And with regard to pharmaceuticals and patents, the administration states it has some concerns. “The United States is concerned that the recent decision by India’s Supreme Court with respect to India’s prohibition on patents for certain chemical forms absent a showing of ‘enhanced efficacy’ may have the effect of limiting the patentability of potentially beneficial innovations. Such innovations would include drugs with fewer side effects, decreased toxicity, or improved delivery systems. Moreover, the decision appears to confirm that India’s law creates a special, additional criterion for select technologies, like pharmaceuticals, which could preclude issuance of a patent even if the applicant demonstrates that the invention is new, involves an inventive step, and is capable of industrial application,” the report states.

	Taylor also expressed PhRMA’s disappointment that Canada was moved to the Watch List for 2013. “While PhRMA appreciates the fact that USTR raises serious concerns regarding numerous Canadian pharmaceutical IP measures, we are nonetheless disappointed that USTR has changed Canada’s designation despite the fact that no progress has been made on this front. Canadian policies and judicial opinions continue to harm international innovators to the benefit of domestic industries. Canadian regulators have, for example, created a discriminatory right of appeal regime under which Canadian medicine manufacturers challenging the validity of a medicine patent may appeal an adverse decision through an administrative proceeding while innovative international biopharmaceutical companies cannot. We also are concerned that the heightened standard for patentable utility for pharmaceutical patents is inconsistent with Canada’s trade treaty obligations. USTR and the interagency process should push Canada to provide more adequate IP protections.”

	The report does express concern regarding rights of appeal in Canada. “With respect to pharmaceuticals, the United States continues to have serious concerns about the availability of rights of appeal in Canada’s administrative process for reviewing regulatory approval of pharmaceutical products and also has serious concerns about the impact of the heightened utility requirements for patents that Canadian courts have been adopting recently.”

	Taylor goes on to state support for USTR and the battle for IP protection. “The value of IP protection should not be undermined by discriminatory market access barriers, including discriminatory government pricing and reimbursement policies. We welcome USTR’s recognition of market access barriers faced by US pharmaceutical companies and their efforts to eliminate them in many countries in order to provide for affordable healthcare today and support the innovation that assures improved health care tomorrow.”

	The full Special 301 Report can be found 

 and details positive and negative findings from countries all over the world.

	What do you think? Is the US doing enough to protect the IP rights of pharmaceutical companies in today’s international market?

Articles

Pharmaceutical Research and Manufacturers of America (PhRMA) International Vice-President Jay Taylor has expressed the organization’s concerns over the Office of the United States Trade Representative’s (USTR) 2013 Special 301 Report.

PhRMA Dismayed by Special 301 Report

 the deployment of an FDA-developed Counterfeit Detection Device (CD-3) as part of a public-private partnership to identify counterfeit or substandard anti-malarial medicines, including falsified products in Africa and parts of Southeast Asia. FDA has partnered with the Skoll Global Threats Fund, the US Pharmacopeia (USP), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the multi-agency President’s Malaria Initiative (PMI), led by the US Agency for International Development (USAID). FDA also announced it has signed a letter of intent with Corning Incorporated to refine and improve the CD-3 tool for eventual manufacture on a larger scale. 

“Fake or substandard anti-malarial drugs cause double damage: without adequate, prompt treatment, the malaria parasite can kill a person in a matter of days, and inadequate treatment can also lead to the development of drug resistance, potentially rendering all treatment ineffective,” said FDA Commissioner Margaret A. Hamburg, M.D., in a press release. “The development of the CD-3 and the formation of this important partnership are critical steps toward the FDA’s goal of improving the global product safety net in order to protect consumers in the US and worldwide.”

 that making detection technology more accessible to low- and middle-income countries would be invaluable in controlling the trade in counterfeit, falsified, or substandard medicines. “The proliferation of counterfeit or substandard medicines around the world is a major public health problem and the developing world is disproportionately affected,” said Commissioner Hamburg, in the release. “The FDA is pleased that CD-3 has the potential to be used as a frontline tool in protecting the global supply chain and make a positive impact on public health efforts to combat malaria in developing regions of the world that are particularly hard hit by the disease.”

The CD-3, developed by scientists at FDA’s Forensic Chemistry Center in Cincinnati, Ohio, is a handheld, battery-operated tool that illuminates a product with a variety of wavelengths of light to provide a visual comparison of an unverified product with an authentic sample, allowing inspectors to identify suspect products and remove them from the supply chain. According to FDA, the effectiveness of the tool in detecting counterfeit or substandard versions of two common anti-malarial therapies will be tested in Ghana in 2013 and 2014, and information obtained from the test in Ghana will guide a second testing program.

FDA will use a new anticounterfeiting tool to detect fake medicines.

FDA Creates Partnership to Battle Anti-Malaria Counterfeit Drugs

	Pharmaceutical manufacturing is evolving as the industry adopts the science- and risk-based approach inherent in FDA’s quality-by-design (QbD) initiative. QbD has raised the bar in augmenting process understanding to ensure consistent product quality, and equipment manufacturers, ingredient suppliers, and manufacturers are responding with innovation in their products and services.

	Shows such as INTERPHEX 2013 enable attendees to come together to share scientific innovation and discuss the trends and topics affecting the industry. One such topic is the QbD initiative and its impact on the pharmaceutical industry. 

 is hosting a panel discussion on implementing QbD during the INTERPHEX sessions, taking place Wednesday, April 24, at 10:15 am. Manufacturing Editor Jennifer Markarian will be moderating a special panel featuring Dr. John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co.; Chris Moreton, vice-president pharmaceutical sciences at FinnBrit Consulting; and Jonathon Thompson, technical sales consulting supervisor at Invensys.  The panel will share their insight and practical experience in implementing QbD, including strategies for defining a design space, adaption of manufacturing processes, the feasibility for real-time release testing, and the keys to continuous process verification. The panel will also discuss the benefits and challenges of QbD implementation.

	Another topic that continually impacts the industry is outsourcing. Jim Miller, a member of 

 Editorial Advisory Board and regular Outsourcing Outlook columnist, will present Wednesday’s Keynote Address on Recalibrating the Pharmaceutical Services Opportunity. Don’t miss Jim’s discussion on the implications of the changing bio/pharmaceutical R&D model for contract service providers.

	Bringing suppliers and pharmaceutical/biopharmaceutical companies together is the focus on the Pharmaceutical Technology/BioPharm International

Marketplace, a new Advanstar and Dun & Bradstreet Credibility Corp. Online Marketplace Community, which connects buyers and sellers with the information and insights they need to collaborate and make purchasing decisions. The Marketplace further delivers valuable information through the Pharmaceutical Sciences, Manufacturing, & Marketplace Report, a biweekly newsletter that reports on the latest technical developments in five main communities: solid dosage, semisolid, and specialty dosage forms; parenterals; pharmaceutical analysis; chemical API manufacturing; and biologic API manufacturing. We welcome you to stop by the 

	We hope you find everything you are looking for at this year’s INTERPHEX, and that you will join Pharmaceutical Technology in the years to come in discussing the topics and innovations that shape the industry.

Pharmaceutical manufacturing is evolving as the industry adopts the science- and risk-based approach inherent in FDA’s quality-by-design (QbD) initiative.

Innovation and Quality by Design, PharmTech’s publisher highlights this year’s INTERPHEX show

  on Monday to healthcare providers, hospital supply managers, and pharmacists that sterile-drug products made by ApothéCure and NuVision Pharmacy were produced under conditions that could create a high potential for contamination. Subsequently, both ApothéCure and NuVision announced voluntary recalls of those products. FDA issued the alert based on preliminary findings of ongoing inspections at ApothéCure and NuVision facilities that raised concerns about a lack of sterility assurance.  

NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5 mL and Sermorelin/GHRH6-5 mL to the user level. According to an FDA

, NuVision Pharmacy has received no reports of injury or illness associated with the use of the sterile products. These products were supplied to the offices of licensed medical professionals. NuVision Pharmacy’s sterile products covered under this recall were distributed nationwide. NuVision Pharmacy is notifying its customers by fax or email to return the products to the pharmacy. Consumers or healthcare providers with questions regarding this recall may contact NuVision Pharmacy by phone at 800-914-7435 on Monday through Friday from the hours of 10 am to 6 pm CST, or by e-mail at 

ApothéCure is also voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the user level. According to an FDA 

, ApothéCure has received no reports of injury or illness associated with the use of its sterile products. However, out of abundance of caution, ApothéCure has decided to voluntarily proceed with this recall process. The sterile products include all injectables with the clear message, “Independently tested for sterility,” noted on the vials as well as the ApothéCure name. Consumers or healthcare providers with questions regarding this recall may contact the company by phone at 800-969-6601 or 972-960-6601 from the hours of 9:30 am to 6 pm CST Monday through Friday or by e-mail at 

. 

FDA advises that patients who have received any product distributed by NuVision or ApothéCure and have concerns should contact their healthcare provider.

FDA inspections of compounding pharmacies manufacturing sterile-drug products lead to voluntary recalls.

Compounding Pharmacies Recall Products

 $4.7 billion as part of the President’s fiscal year (FY) 2014 budget. A portion of the budget increases would support programs to ensure the safety of medical products. 

The budget also includes a $15-million decrease in budget authority for human drug, biologics, and medical device programs. “These are tight budget times, and the FDA budget request reflects this reality,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, in a press release. “Our budget increases are targeted to strategic areas that will benefit patients and consumers and overall strengthen our economy. Through the good work of the FDA, Americans will receive life-saving medicines approved as fast as or faster than anywhere in the world, confidence in the medical products they rely on daily, and a food supply that is among the safest in the world.”

The FDA budget request includes more than $17.9 million more than FY 2012 for outfitting and required certification and operation of the Life Sciences-Biodefense Complex (the FDA’s White Oak headquarters in Silver Spring, Md.) to modernize regulatory science and promote medical product innovation. It also includes more than $10 million above the 2012 budget for food and drug safety inspections of products and ingredients manufactured in China.

FDA's Fiscal Year 2014 budget request includes more than $10 million above the 2012 budget for inspections of products manufactured in China.

FDA Requests Almost $5 Billion for 2014 Budget

, FDA Commissioner Margaret Hamburg stated that recent FDA inspections of 31 compounding pharmacies known to produce sterile drugs resulted in a discovery of inappropriate sterile-manufacturing conditions and FDA-483 observation results for all but one of the companies inspected. The companies were cited for incidents ranging from rust and mold in cleanrooms to unidentified black particles in vials of sterile product. Some of these FDA-483 notices have led to voluntary product recalls.

According to Hamburg, FDA was met with resistance from some of the pharmacies that were included in the inspections. She claims that some inspections were either delayed or inspectors were denied full access to records, thus requiring court-issued warrants. “These inspectional observations reveal that there continues to be reason for concern about sterility deficiencies and other problems in some compounding pharmacies across the country–problems that could potentially affect the health of patients. To carry out this proactive inspection effort, FDA had to shift resources from other areas, and this is not a sustainable approach for the longer term,” Hamburg stated on FDA.gov.  

Hamburg also stated that FDA is working with Congress on legislation for FDA oversight of compounding pharmacies and is evaluating the agency’s surveillance and enforcement approach. 

FDA inspections of compounding pharmacies manufacturing sterile products reveal non-sterile conditions.