The Safety of Generic Drugs : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

These exhaustive laboratory tests have enabled FDA to protect consumers from generic drugs that do not conform to current standards. It is our belief that this process allows us to solve the issue at hand — ensuring the quality of generic drugs.

In addition to testing the top 30 generic drugs, we launched a second wave of inspections involving 20 additional drug companies that manufacture generics. These inspections, which also include some brand-name makers who make generic drugs as well, were not prompted by any wrongdoing; rather, the firms were selected because they market a broad array of generics.

It is important to note that we have not received any unusual reports of quality problems with the use of these drugs. We took these actions because we felt they were warranted, given the serious allegations of misconduct that came to light earlier this year.

The plan of action put forward with the secretary's help will, we hope, prevent problems such as the ones I've outlined from recurring.

First, in addition to the plan's call for expanded field inspections, we are reorganizing and strengthening the generic drug review procedures. We are recruiting proven managers to oversee a reorganized and enhanced Office of Generic Drugs, and are establishing a quality control function to make sure that our reviews of new generic drugs are fair and based on sound science. This new office will have increased staff and will report to the director of the Center for Drug Evaluation and Research, Dr. Carl Peck.

Second, we are creating a technical scientific advisory committee on generic drugs. Drawing on the approach successfully used in other FDA product review areas, this committee will provide expert outside counsel on problematic and complex scientific issues.

Additionally, we are establishing an independent ombudsman who will report directly to me. This ombudsman will investigate and seek to resolve disputes between FDA and companies that feel disadvantaged, and pursue complaints that involve potential problems of safety, effectiveness or fairness involving approval of generic drugs as well as other FDA-regulated products.

Fourth, we will work more closely with the inspector general of HHS. As in the past, the inspector general will support FDA in criminal investigations when FDA requests this assistance. We will also continue to work closely with the inspector general should any matters arise that involve charges of wrongdoing by FDA employees.

Fifth, as noted earlier, we are working with HHS in developing legislation to strengthen the department's authority to act promptly against criminal activity in connection with the drug evaluation process.

Finally, we are continuing to seek ways to finance these activities and others carried out by the agency to protect and serve the American consumer.

The actions of a few individuals have seriously eroded the honor system upon which much of the generic drug review process has been based. Now, we will strengthen that system with a "trust, but verify" approach.

Throughout the generic drugs saga, I've been frequently asked what I would advise a patient who was taking generic prescription drugs. My advice is simple: If the medicine is working, continue to take it. If you are given a new prescription and want to take the generic version of the drug, consult your physician or pharmacist. They will have the latest information on any problems that may exist with respect to prescription drugs, both brand-name and generic.

I've always been an advocate of greater communication between patient and physician. The silver lining to the cloud of the generics investigation is that it may have encouraged patients to take a closer look at the medicines they were taking and to discuss them with their doctors.

I believe that, ultimately, the combination of FDA's continued efforts to ensure safety and effectiveness and better communication between patients and physicians will mean that the nation's confidence in the prescription medicine supply will be stronger. That's a pill we all can swallow.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.