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The negotiations under way to control government spending and reduce the deficit have the potential to impact pharmaceutical revenues. A proposal is on the table to increase drug rebates under Medicare Part D as a means of controlling the overall costs of the Medicare program. The Pharmaceutical Research and Manufacturers of America (PhRMA) is opposed to such measures, concerned that a decrease in revenues could damage a healthy and growing industry and that the ripple-effects from a slowdown in biopharmaceutical growth could negatively impact an already fragile economy. In a press release, PhRMA president and CEO John J. Castellani issued the following statement:

In early July 2011, FDA provided an update in which the agency said that it has made progress toward implementing the US Food Safety Modernization Act (FSMA), which was enacted in January 2011. In addition to clarifying expectations for new dietary ingredients through new draft guidance, the agency has issued an antismuggling strategy.

The Society of Chemical Manufacturers and Affiliates (SOCMA) issued its support this week of the passage of pending free-trade agreements (FTA) with South Korea, Panama and Colombia by two Congressional committees. SOCMA is the US-based trade association representing custom and batch manufacturers, including contract manufacturers of fine chemicals, pharmaceutical intermediates, and active pharmaceutical ingredients.

The European Medicines Agency (EMA) has detailed plans for granting public access to information concerning the potential side effects of medicines. Members of the public will be able to access data in the EudraVigilance database-EMA?s central repository for reports of suspected adverse reactions related to authorized medicines in the European Economic Area, as well as those being studied in clinical trials.

FDA banned the importation of products manufactured at the Mexican unit of Dr. Reddy?s Laboratories, according to Reuters. The import ban is a result of the company?s failure to correct the violations listed in a June 3, 2011, Warning Letter to the agency's satisfaction.

Members of the House Energy and Commerce Committee are expanding their investigation into the 2008 entry of contaminated heparin from China into the United States (US) market.

An FDA panel has voted unanimously to withdraw approval for Roche?s Avastin for use in the treatment of metastatic breast cancer because there is not enough data to support the conclusion that the benefits outweigh the risks. The fate of Avastin in this indication now lies in the hands of FDA Commissioner Margaret Hamburg, who will make the final decision after the period for public comments closes at the end of July. Roche will also have the opportunity to submit its final summary on the matter.

FDA issued a draft guidance, entitled ?Q11 Development and Manufacture of Drug Substances,? which is now available for comment according to a notice published on June 29, 2011, in the Federal Register. The draft guidance was developed in conjunction with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and describes approaches to developing process and drug substance understanding. It also provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD).

The European Medicines Agency (EMA) has responded positively to a new directive published in the Official Journal of the European Union addressing concerns over increases in falsified medicines in the supply chain. The directive comes into effect on July 21, 2011, and EMA will be working closely with its partners and the European Commission (EC) on implementation over the next 18 months. Member states will have to begin applying the measures beginning January 2013.

At last week?s 2011 Partnering for Global Health Forum, sponsored by the Biotechnology Industry Organization and BioVentures for Global Health, a unique panel of government leaders from emerging markets discussed what it takes to do business in their countries.

Data has highlighted the pharma industry's high rate of Phase III drug terminations and significantly reduced research and development (R&D) spending. According with Thomson Reuters, 2008?2010 saw more than double the number of Phase III terminations compared to 2005?2007, while pharmaceutical R&D spend, in general, hit a three-year low in 2010. The information has been published in the 2011 edition of the Pharmaceutical R&D Factbook, compiled by Thomson Reuters? CMR International unit. A press statement from Thomson Reuters also added that the clinical trials dropout rate is at ?unsustainable levels.?

In a speech at Carnegie Mellon University?s National Robotics Engineering Center last Friday, President Obama unveiled an Advanced Manufacturing Partnership (AMP) designed to reinvigorate the country?s manufacturing sector. The partnership between academics, business leaders, and science and technology agencies is intended to create jobs by helping US manufacturers reduce costs, improve quality, and accelerate product development.

The International Pharmaceutical Excipients Council (IPEC) Federation issued a statement on the use of phthalates in pharmaceutical products in response to reports of adulteration of certain nutritional supplements, vitamins, foods, and beverages imported from Taiwan. Two phthalates, di-ethyl hexyl phthlate (DEHP) and di-isononyl phthalate (DINP), which are commonly used as plasticizers for polyvinyl chloride (PVC)-based plastics, were found in certain adulterated products and subsequently recalled by Taiwan authorities. It is believed that the phthlates were added as a form of economically motivated adulteration as a low-cost replacement for palm oil.

GlaxoSmithKline (GSK) has entered into an agreement to purchase Shenzhen Neptunus' stake in a previously formed joint venture between the companies involved in the development and manufacture of influenza vaccines in China, Hong Kong, and Macau. GSK will pay Shenzhen Neptunus $39 million, after which GSK will be the sole owner of the joint venture company, Shenzhen GSK-Neptunus Biologicals (GSKNB).

Merck & Co. and the biobusiness of Hanwha Chemical, a Korean chemical manufacturer, have formed an exclusive global agreement to develop and a commercialize a biosimilar of Enbrel (etanercept), a drug to treat moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis.

Nanotechnology is science involving particles less than 100 nm in size. It is an emerging technology that is finding applications in medical products, food packaging, and cosmetics. Nanoscale materials can have different chemical, physical, or biological properties than their conventionally-scaled counterparts. As a first step in providing regulatory clarity about the use of such technology, FDA issued a draft guidance, titled "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology" on June 9, 2011. The guidance lists points that FDA will consider when determining whether a product applies nanotechnology, and explains rationales for those points.

After looking back at the first year of its Bad Ad outreach program, FDA judged that the initiative has successfully raised awareness about misleading promotion, according to an FDA press release. The program, which was intended to educate healthcare providers about misleading drug promotions, debuted on May 11, 2010. Since that time, the agency has received 328 reports of potentially untruthful promotion. In contrast, FDA received an average of 104 reports per year before the initiative was launched.

Believing that transparency in the pricing of medicines is ?fundamental? to enabling patients and stakeholders to make proper decisions about equity and value for money in health systems, the European Public Health Alliance (EPHA) called for greater pricing transparency. EPHA also called for the formation of a public website that provides comparative information on medicines? procurement prices. EPHA?s calls are a response to the European Commission?s consultation on the possible revision of Directive 89/105/EEC, which concerns the transparency of the pricing and reimbursement of medicines in various member states.

A South Carolina court found that Ortho-McNeill-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson (J&J), violated state consumer-protection laws by using misleading marketing for its antipsychotic drug, Risperdal. Janssen Pharmaceuticals, the maker of the drug, received a Warning Letter from FDA in April 2004 over misleading product claims made in a ?Dear Doctor? letter that the company sent to healthcare providers in November 2003. According to FDA, the Janssen promotional material minimized the risks of hyperglycemia-related adverse events associated with Risperdal, and misleadingly claimed that Risperdal was safer than other atypical antipsychotics.

The FDA Center for Drug Evaluation and Research's Office of Compliance is undergoing some major structural reorganization, according to an internal letter to the CDER staff from Director Janet Wookcock, dated May 26, 2011, which was shared with Pharmaceutical Technology by the agency press office. Specifically, the Office of Compliance will be elevated to a "Super Office." Similar offices exist within CDER including the Office of Pharmaceutical Science. The change means that the Office of Compliance will house subordinate offices, including four new offices, three of which are similar to existing divisions, according to the letter. The new fourth office will be called the Office of Drug Security, Integrity & Recalls (ODSIR) and will focus on addressing the challenges of globalization and an increasingly complex drug supply chain. This includes dealing with supply-chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls, according to the announcement.

The US Supreme Court, in a decision concerning the patent rights of research universities, ruled in favor of Roche in a patent-dispute case between the pharmaceutical company and Stanford University. In a 7?2 vote, the Court upheld a lower court?s decision that Stanford did not have a claim to patents for technology to detect HIV blood levels using polymerase chain reaction (PCR) technology.

This week, AstraZeneca agreed to settle a sex-discrimination lawsuit by paying $250,000 to 124 women who worked at the company?s Philadelphia Business Center in Wayne, Pennsylvania. The US Department of Labor (DOL) brought the lawsuit in May 2010, alleging that AstraZeneca had discriminated against female sales specialists by paying them salaries that were an average of $1700 less than those of their male counterparts.

An independent report released by the European Medicines Agency on May 31, 2011, highlighted a number of recommendations to aid the agency in its communication of the benefits and risks of medicines. The report was the conclusion to a one-year project conducted by Frederic Bouder, PhD, at the behest of EMA, aiming to provide detailed, evidence-based input by analyzing the expectations and attitudes of the agency?s stakeholders toward communication on medicines.

Mylan, a generic-drug manufacturer, announced that it will be rebranding its Hyderabad, India-based subsidiary, Matrix Laboratories, as Mylan. In a company press release, Mylan Chairman and CEO Robert J. Coury states: ?This rebranding will lay the groundwork for continued expansion in India through our entry into the Indian commercial market with our own prescription pharmaceuticals within the next 12 months.? Matrix Laboratories is a supplier of active pharmaceutical ingredients (APIs), and a producer of APIs used to make generic antiretroviral therapies for the treatment of HIV/AIDS. Mylan acquired 51.5% of Matrix?s shares in 2007, and the remainder of its shares in 2009.

During an eight-day series of meetings that concluded on May 24, 2011, the World Health Assembly, the decision-making body of the World Health Organization, passed 28 resolutions and adopted three decisions to guide the organization?s work and address global health issues. The sessions were held in Geneva during the annual meeting of the World Health Assembly. More than 2700 delegates attended, including government health ministers, senior health officials, nongovernment organizations, civil-society groups, and observers.

Last week, FDA added a searchable database of inspection data to its website. The database lists the names and addresses of facilities that the agency inspected during fiscal years 2009 and 2010. Users can find inspection dates, the type of FDA-regulated products that the facilities produced, and the agency?s final inspectional classification, which reflects each firm?s compliance status.

The pharmaceutical industry has been called to action by a new report that highlights the health and cost repercussions of patient noncompliance. According to Capgemini?s report, Patient Adherence: The Next Frontier in Patient Care, patient adherence to medications for chronic conditions, such as HIV and Arthritis, averages at only 50%.

On Monday, Teva Pharmaceutical Industries agreed to pay shareholders $460 million in cash to acquire a 57% stake in Taiyo Pharmaceutical Industry. Teva also will offer to buy all outstanding shares of Taiyo. The deal values Taiyo at approximately $1.3 billion.