Generic Focus

Pharmacy TimesMay 2012 Skin & Eye Health
Volume 78
Issue 5


The Generic Drug Application Review Fairness Act of 2012 would make 2 important improvements to the Food, Drug, and Cosmetic Act that would ensure continued access to high-quality, low-cost generic medicines. The bipartisan bill was recently introduced by Reps Frank Pallone (D, New Jersey) and Brett Guthrie (R, Kentucky).

Generic drug manufacturers that are the first to challenge a patent of a branded pharmaceutical receive 180 days of market exclusivity upon approval. Eligibility for this approval, however, means they must receive tentative FDA approval within 30 months, while the median approval time for generic drugs exceeds 30 months. The bill would temporarily double to 60 months the time in which a generic must receive FDA approval. Over the next 5 years, that time would gradually decrease, returning to 30 months in 2017.

The bill would also modify the organizational structure at the FDA so the Office of Generic Drugs (OGD) would report directly to the director of the Center for Drug Evaluation and Research, giving it the same stature as the Office of New Drugs. This direct access would provide the OGD with the ability to access more financial resources within the agency, and accelerate decision making regarding new policies and procedures.


The Biotechnology Organization (BIO) expressed its support for funding of the FDA in its attempts to bring biosimilars to the US market during testimony before the Senate Health, Education, Labor, and Pensions Committee on biosimilar user fees (BsUFA) and the Prescription Drug User Fee Act (PDUFA).

In her April testimony, Sarah Radcliffe, MPH, executive vice president of health at BIO, said, “A transparent, predictable, and balanced regulatory framework for the review and approval of biosimilars, accompanied by reasonable performance goals and a dedicated, independent funding stream, will ensure that FDA can facilitate the development and evaluation of biosimilars products.”

She also testified in strong support of the PDUFA V recommendations, which would improve the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen postmarket surveillance. The recommendations include enhancements that aim to reinforce the FDA’s review performance with the goal of minimizing development and review issues that can delay patient access to needed treatments.

“Both user fee programs will enhance FDA’s ability to protect and promote the public health, and we encourage Congress to enact both legislative provisions in a timely manner,” concluded Radcliffe.

Also testifying at the Senate hearings, the Generic Pharmaceutical Association reiterated its call for Congress to act without delay on the historic user fee proposals recently negotiated by industry and the FDA for both generic drugs and biosimilar products.


The research firm IBISWorld has added the Generic Pharmaceutical Manufacturing market Research Report to its growing industry report collection. IBISWorld cited continued growth in the generic industry, patent expirations of brandname drugs, and health care reform as reasons for adding this report.

The $52.8 billion generic pharmaceutical manufacturing industry continues to outpace the growth of the brand-name pharmaceutical industry. During the 5 years to 2012, industry revenue increased at an average annual rate of 5.4%, according to the report. IBISWorld expects revenue will continue to increase in 2012 due to the improved economic climate and the most significant year of the brand-name drug patent cliff.

Brand-name manufacturers faced a considerable patent cliff beginning in 2011. In 2012 and the years ahead, several blockbuster branded drug patents are set to expire, opening up the market to generic versions. As a result, industry sales will be stimulated but long-term viability of generics will be hindered, because fewer innovative drugs are being developed. In response, generic manufacturers are moving into biosimilar production.

The report also noted that the number of companies continues to grow as entrants are enticed by the industry’s strong profit margins. During the 5 years preceding 2012, the number of operators is expected to increase to 1103, representing an average annual growth of 1.6%. As generic companies have grown, they have developed an even greater need to consolidate because biologics are becoming a larger portion of industry sales.

The report concluded that the continued growth in the generic industry will attract new entrants, but sustained consolidation will hamper the increase in the number of operators. Furthermore, health care reform will significantly benefit the industry, with more consumers gaining coverage for prescription drugs, improved generic approval processes, and an established pathway to approval for biosimilars.


A proposed bill would allow generic drug manufacturers to update medication labels but would also open the companies to patient lawsuits.

Introduced on April 18, 2012, in the House and the Senate, the bill would permit generic drug manufacturers to update the warning labels on their products, according to an article in The New York Times. As a result, patients would be able to sue generic companies for failing to warn them about the risks of taking a generic medicine.

The bill challenges a 2011 Supreme Court decision barring patients from going to court over severe side effects from or reactions to a generic medication. That decision, Pliva v Mensing, stated that generic companies exercise no control over drug labels and could not be brought to court for adverse side effects that were not included on the labels. An earlier Supreme Court ruling permitted suing brand-name manufacturers over adverse side effects or reactions.

According to The New York Times, dozens of lawsuit against generic drug manufacturers have been thrown out, even though many cited the same injuries as those seen in brand-name suits. Current laws state that only brandname companies can update drug labels. Generic manufacturers are required, however, to replicate changes to the brand-name label.

Generic drug companies dispute the bill, citing the possibility of conflicting warning information from drug companies. In addition, Generic Pharmaceutical Association (GPhA) President and Chief Executive Officer (CEO) Ralph G. Neas stated that the legislation would place an unnecessary burden on physicians by forcing them to remember multiple product labels.


Generic drug companies can challenge how brand-name manufacturers describe their drug patents after a Supreme Court ruling handed down on April 17, 2012.

According to an article appearing in The Wall Street Journal, the decision allows generic drug companies to dispute broadly worded brand-name patents on the grounds that the phrasing can exclude generic competition.

According to GPhA, the Hatch— Waxman Act’s counterclaim provision permits generic drug manufacturers to market their products for approved uses that are not covered by any patent. The counterclaim provision allows the FDA to approve a “carve-out” label that allows generic companies to avoid patent infringement lawsuits.

The ruling involved a case between generic drug manufacturer Caraco Pharmaceutical Laboratories and Novo Nordisk and the introduction of a generic version of the diabetes drug Prandin (repaglinide). Caraco Pharmaceutical could not introduce its generic version of the drug because the brand-name patent description was too broad, the article stated.

“We commend the Supreme Court for preventing Novo Nordisk’s actions from becoming a playbook for all brands and costing consumers millions of dollars by delaying the introduction of affordable, lifesaving generic drugs,” Ralph G. Neas, GPhA president and CEO, said in a release.


GPhA selected IMS Health to supply real-time drug shortage information to the FDA as part of the association’s plan to replenish supplies of critical medicines.

IMS Health, which provides information, services, and technology to the health care industry, will work in conjunction with the FDA’s existing efforts. The type of information gathered and disseminated will increase early visibility and communication between the FDA and the industry relating to current and potential drug shortages.

The agreement would use voluntary communication between IMS Health and stakeholders involved in manufacturing and distributing generics that are in short supply. The real-time supply and distribution information would give the FDA a better understanding of current conditions, expand the supply of critical medications, and avert future shortages.

The move is part of the GPhA’s Accelerated Recover Initiative, a multi-pronged effort to ensure patients have access to life-saving generic medications.

“IMS commands the respect of all stakeholders and has a reputation for confidentiality. Their unique ability to collect, process, and communicate the complex manufacturing data the ARI requires will be essential to the initiative’s success,” Ralph G. Neas, president and CEO of GPhA, said.

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