From New Jersey to New Delhi, a global focus on quality

By: Howard Sklamberg and Cynthia Schnedar

As we walked through the bustling, ancient city streets of Old Delhi last week, teeming with tourists and shop keepers selling spices and saris, we were struck by how resplendent this country is, and just how much it offers the world.

Howard Sklamberg

Howard Sklamberg, J.D., FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

This is certainly true about prescription drugs. India is a significant exporter of generic drugs to the United States. The American people benefit tremendously from generic drugs, as more and more generic medications reduce costs for patients, and the American healthcare system. The rise of India’s pharmaceutical star is one of the reasons why our trip to India is so important.

While here, we have had a chance to meet with our regulatory counterparts in the Indian government, as well as the drug manufacturers that are either based here, or who have facilities in the country. Needless to say, we are learning a great deal.

It’s no secret there have been challenges associated with the quality of generic drugs coming out of some facilities in India. Some people have asked us here if the FDA is “singling out” India for increased inspections. We simply reply that increased exports to the U.S. result in increased inspection, no matter where you are in the world. FDA inspections ensure that when a firm wants to export drugs to the United States, the drugs meet FDA standards and will be of the quality patients and consumers want and deserve.

Cynthia Schnedar

Cynthia Schnedar, J.D., Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research

And we’ve been happy to hear that this focus on quality is, in fact, a shared goal, held by both the Indian — and India-based — regulators and pharmaceutical manufacturers with whom we’ve met. They understand what we mean when we tell them the FDA is interested in helping to build a global network of quality; that it doesn’t matter whether a drug is made in Hoboken or Hyderabad, if it is intended for use in the United States, the drug, and the way and under what conditions it’s produced, will be reviewed using the same standards and levels of scrutiny.

That scrutiny, by the way, doesn’t always have to have negative results. The inspections associated with drug production have been a central discussion point on this trip, and we’ve brought news that has been well-received, especially by the drug industry. We shared our proposed plan to create a new approach to facility inspections, one that will not only note problems, but will also allow our inspectors to document where a firm’s quality management system exceeds what would be required to meet regulatory compliance. To put it simply: the inspections can yield also carrots, and not just sticks.

Meeting in India

Last week, FDA’s Howard Sklamberg and Cynthia Schnedar participated in a panel discussion on drug quality with drug associations in India

So what are the carrots? These findings could be used to influence the frequency of our inspection of a particular facility, and possibly even support regulatory flexibility around post-approval manufacturing changes. These kinds of decisions would be anchored by data that proves that the risks of manufacturing problems in a certain facility are minimal.

We have often said we cannot inspect our way to absolute drug quality. Many of our discussions on this trip have focused on the importance of firms enhancing their own “quality cultures.” And, to that end, we know there are initiatives we can take to help them succeed. For example, we will be piloting a new questionnaire that could be used to further standardize inspections, with the goal of uniformly harvesting the kind of data that supports accurate measures of quality. We believe that by improving the inspection process in this way, future “metrics” that define quality will be understood and aspired to by manufacturers — no matter where they are in the world.

CEO meeting in India

Last week, FDA’s Howard Sklamberg and Cynthia Schnedar met with pharmaceutical CEOs in India to discuss drug quality

Of course, enforcement has been, and will continue to be, an important part of our program to ensure drug quality. Enforcement is a particularly appropriate tool when a firm does not submit accurate data to us. FDA relies on information to do its job, and faulty information means that we cannot ensure the quality of the drugs that the firm produces.

It is already clear to us, after speaking with regulators and industry leaders here, that India intends to be part of that global community that is committed to producing the highest quality of drugs possible. Through workshops and joint inspections, we continue to work with the Indian government to raise awareness and understanding of our inspections processes. And to the industry leaders we have met with here, we have pledged to continue to collect their feedback on how we might be able to help them improve regarding quality issues, and to incentivize them to do so.

India has a significant spot in the constellation of drug-producing nations. As one Indian official so eloquently said to us, we have “a galaxy” in common. And, we are happy to add, that the brightest star in that galaxy may just be our shared commitment to a global system of drug quality.

Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Cynthia Schnedar, J.D., is Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research

Celebrating 30 years of easier access to cost-saving generic drugs

By: Margaret A. Hamburg, M.D.

Thirty years ago today, President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984, better known today as the Hatch-Waxman Amendments. This law, championed by Senator Orrin Hatch and Representative Henry A. Waxman, made it easier for generic drugs to enter the market, and has greatly expanded access to important—often life-saving—drugs. Over the 10-year period 2003 through 2012, generic drug use is estimated to have generated more than $1.2 trillion in savings to the health care system and to have benefitted the health and well-being of innumerable lives.

Margaret Hamburg, M.D.Thanks to the insight of its creators, one of the strengths of this law is the fact that it provided financial incentives for pharmaceutical companies that develop and manufacture new and innovative trade name products. Under the law, sponsors of qualifying trade name drugs are provided an opportunity to extend a patent to make up for patent life lost during the process of testing and approval of the product.

The law also, however, provided a clear pathway to market for generic drugs. Before Hatch-Waxman, little more than a third of branded prescription drug products even had a generic available, and those that were available were not as widely used. Today, most drugs that go off patent face competition from cost-saving generic drugs. As a result, about 85 percent of all prescriptions filled are for generic versions.

Importantly, while Hatch-Waxman has provided powerful cost savings for American consumers, its value in providing greater access to medication cannot be overlooked. For over 30 years, millions of consumers who otherwise would not have been able to afford needed medication now have access to lower-cost, quality, generic drugs that are just as safe and effective as their brand-name counterparts.

Despite the enormous success of Hatch-Waxman, FDA faces challenges as we continue efforts to ensure access to affordable and quality generic drugs.

FDA is working to reduce the current backlog of generic drug applications for new generic drug products. Fortunately, the Generic Drug User Fee Amendments of 2012, GDUFA for short, provides additional funding for FDA’s generic drug program. We’re allocating significant time and money towards reducing the backlog.

As our world economy experiences greater globalization, it has becoming increasingly important for FDA to allocate its resources based on potential risk around the globe. More than 80 percent of the ingredients used to make our drugs now come from overseas suppliers. FDA is committed to working to ensure that, no matter where the ingredients are from or where the drugs are made, the American public can be assured their products are safe. GDUFA funding also helps FDA address global inspections, and we are diligently working to monitor production across the globe.

FDA salutes the vision of Senator Hatch and Representative Waxman. Their landmark legislation has improved the health of generations of Americans. And we’re proud of the role FDA has had in implementing Hatch-Waxman and helping to assure its success. We look forward to continuing to enhance Americans’ access to safe, effective, and affordable generic prescription drugs.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

Working to improve the communication of important drug safety information about generic drugs

By: Janet Woodcock, M.D. 

FDA is taking a step today that is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients. 

All drug manufacturers are required to keep close tabs on their drugs once they go to market, reviewing all reports of adverse events involving their drug and reporting these findings to FDA. 

But currently, only brand name manufacturers are able to independently update and promptly distribute revised drug safety information, also called labeling, and they can distribute that information before FDA has reviewed or approved the change. These updates, which are submitted in changes being effected supplements, ensure that this important safety information gets to the public as quickly as possible. 

Right now generic companies, who are responsible for over 80% of the prescription drugs dispensed to patients, aren’t able to revise their drug safety information as quickly as the brand name. They must provide supporting information to FDA, which then determines whether safety information for both the brand and generic drugs should be revised before updates can occur. 

Today, FDA is issuing a proposed rule that would allow generic drug manufacturers to independently update and promptly distribute revised product labeling — just like brand name manufacturers – before FDA reviews or approves the change. 

Empowering generic drug companies to update their own drug safety information is intended to provide them the incentive to more actively participate with FDA in ensuring the timeliness, accuracy, and completeness of this information. 

The brand manufacturer would be expected to consider the information provided by the generic drug manufacturer as part of its review and evaluation of adverse drug experience information for its drug. 

And to make sure that the drug safety information updates from both generic and brand name companies are readily available to health care professionals and the public, FDA plans to post these updates on its website. 

Faster safety updates and easier access to this information should be a win–win for all involved. 

Janet Woodcock, M.D., is director of FDA’s Center for Drug Evaluation and Research