U.S. Drug Safety System Testimony

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Comments of the U.S. Public Interest Research Group (U.S. PIRG)

Committee on the Assessment of the U.S. Drug Safety System
The National Academies Institute of Medicine

July 19, 2005

Good afternoon. My name is Lindsey Johnson, and I'm a consumer advocate at the U.S. Public Interest Research Group (U.S. PIRG). U.S. PIRG is the national advocacy office for the state Public Interest Research Groups. State PIRGs are non-profit, non-partisan public interest advocacy organizations.

The most essential step towards improving the FDA's drug safety system is restoring balance to the agency. Currently, at the FDA, the scales at each decision point are tipped decidedly in the direction of the pharmaceutical industry. The State PIRGs support a combination of organizational changes, new authorities, and increased resources to ensure that the FDA gives fair consideration to the safety and well-being of American consumers as well as the concerns of the drug industry. Senator Grassley and Senator Dodd have introduced the FDA Safety Act of 2005, strong legislation that encompasses the majority of our recommendations.

I will discuss three key areas of the FDA's drug safety system that must be strengthened in order to restore balance to the agency and help it protect consumers from dangerous medical products.

1) The FDA's Ability to Make Unbiased Decisions About Drug Safety

2) The FDA's Ability to Effectively Regulate the Drug Industry

3) The FDA's Ability to Monitor Direct-to-Consumer Advertising

1) Strengthen the FDA's Ability to Make Unbiased Decisions Drug Safety

The FDA's organizational structure hampers the agency's ability to effectively respond to new evidence of dangers with FDA approved drugs. One director-the director of Center for Drug Evaluation and Research or CDER-administers an imposing range of critical work conducted by twelve offices (including the Office of Compliance and the Office of New
Drugs) and their thirteen sub-divisions (including the Office of Drug Safety and the Office of Generic Drugs).

Researchers in the Office of Drug Safety (ODS) are under the management of the Office of Pharmacoepdimemiology and Statistical Science. In turn, the Director of the CDER, has authority over both the Office of Pharmacoepdimemiology and Statistical Science (OPSS) and the Office of New Drugs (OND). Unfortunately, the view points of the Office of Drug Safety and the Office of New Drugs are often not given equal weight for at least two reasons:

1) Since the passage of the Prescription Drug User Fee Act, funding for most of the FDA's critical drug research functions-with the exception of new drug approval-has declined. In the past 11 years, spending on new drug reviews increased from 53 percent to more than 79 percent of the agency's drug center budget. Because the OND is a source for a large percentage of the agency's drug-related funding, the OND perspective on controversial issues has a strong advantage over the perspective of other offices.

2) Secondly, the Director of CDER oversees the approval process for new drugs as well as the response to emerging safety concerns about FDA approved drugs. For the Director, acknowledging that there are unacceptable risks in FDA approved drugs, is tantamount to admitting that the OND failed to recognize or address a dangerous side-effect.

We support creating a new independent drug safety office (such as the Center for Postmarket Drug Evaluation and Research proposed in the FDA Safety Act) that would be on equal standing with CDER. The new center would evaluate post-market studies and make recommendations directly to the Commissioner of Food and Drugs. This would strengthen the FDA's ability to make unbiased decisions about the safety of approved prescription drugs. The creation of a new, independent drug safety office would restore balance to the agency and foster an environment that is more responsive to drug safety concerns. (For a graphical depiction of current and proposed chain of command, please refer to the attached chart.)

Also critical to strengthening the FDA's ability to make unbiased decisions, is improving the FDA's capacity to identify and gather information about potentially dangerous drugs. The current FDA system for monitoring the safety of drugs on the market, MedWatch, largely relies on doctors to voluntarily alert drug companies. Although a passive reporting system has its limitations, if properly utilized it could provide early indications of emerging safety risks. We encourage the committee to consider ways to revitalize the Medwatch system-such as additional funds to modernize the system and public awareness efforts to inform consumers and health care providers on how to report adverse drug events directly to the FDA. Increased reporting will increase the system's value.

A more active monitoring system should be developed to further improve the FDA's ability to research adverse drug events. We support empowering the FDA to utilize a range of data sources (such as contracting with large health care providers) to track the health outcomes of patients taking particular drugs.

2) Strengthen the FDA's Ability to Effectively Regulate the Drug Industry

Again, the key to an effective drug safety system is balance. The safety of a prescription drug must be balanced with the medical need for the drug. The FDA needs a range of options to address the safety hazards of a particular drug or biological product with a particular safety strategy. With its existing authority, the FDA has a very limited ability to influence a drug company's behavior. Short of actually pulling a drug from the market, the FDA lacks the authority to force drug companies to take appropriate action to reduce the risks to consumers.

The FDA should have a wide array of corrective actions or safety strategies to employ when it suspects that a drug may cause serious side effects. New authorities that would give FDA the power and flexibility to mitigate the known and unknown risks of drugs include:
- Requiring a change to the drug's label by specified date
- Restricting prescriptions or distribution of the drug to ensure appropriate usage
- Requiring the sponsor of the drug to establish a patient registry
- Requiring patients to sign a consent form prior to receiving a prescription
- Requiring the sponsor to create a risk management plan
- Modifying the approved indication of the drug

With these authorities, the Director would have the flexibility to require a corrective action that protects consumers without preventing health care providers from prescribing the drug to patients that need it.

Most importantly, the FDA needs the authority to compel drug companies to conduct postmarket safety studies on approved drugs. The FDA already asks drug companies to perform additional studies, but has no authority to force companies to comply with their request. This authority, as with the authorities previously mentioned, must be enforceable with significant financial penalties for companies that fail to fulfill the FDA's requests.

3) Strengthen the FDA's Ability to Monitor Direct-to-Consumer Advertising

The FDA's ability to protect consumers from dangerous prescription medication will be limited until the FDA can effectively monitor direct-to-consumer (DTC) advertising. DTC advertisements of prescription drugs, must fairly balance the benefit of the drug with the risks associated with taking the drug. Currently, even when the FDA finds that drug companies are improperly representing the safety or efficacy of their products, the ads have already been viewed by millions of consumers.

Instead of always struggling to catch up with the drug industry's prolific use of advertisements, we support giving the FDA the ability to review DTC advertising before the ads are aired or published.

In particular, the drug companies should be held to a stricter standard on materials to promote drugs in the first 2 years after final approval-newly approved drugs are inherently more risky because they have been used by a limited number of people. This requirement would prevent drug companies from knowingly misleading consumers about the risks and benefits of newly approved prescription medication. Drug companies should be required to follow explicit promotional material guidelines for informing consumers about both identified risks and ongoing studies

Conclusion

The State PIRGs strongly support the FDA Safety Act, and encourage the committee to impress upon Congress the importance of acting quickly to pass strong reforms. The FDA Safety Act of 2005, by Senators Grassley and Senator Dodd, would improve the FDA's ability to protect consumers by restructuring the agency to encourage a renewed emphasis on drug safety, granting the FDA new authorities to effectively regulate a powerful industry, and increasing the amount of resources allotted to the agency's drug safety efforts.

Reforms cannot restore balance to the FDA's drug safety system, until the agency receives adequate funding. We urge you to ask Congress to give the FDA the resources, the authority, and the independence from the drug approval process to protect consumers from dangerous medications. Without these reforms, thousands of consumers will be harmed or even killed just because they filled their prescriptions.

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