When it comes to medicines, safety has many meanings and many stakeholders: Volunteers in clinical trials, researchers and technicians working in laboratories and manufacturing facilities, regulators at the Food and Drug Administration (FDA), physicians prescribing medicines, and patients who rely on those therapies to lead healthier, longer lives—all have vested interests in drug safety. The safety and integrity of medicines is critical to America’s biopharmaceutical industry and the patients we serve.
Developing safe and effective medicines
Ensuring the safety of a medicine begins long before it enters the marketplace and continues long after it is available to patients. Pharmaceutical companies collaborate with the FDA during every phase of drug development. The rapidly increasing pace of medical innovation requires an efficient yet thorough approval process.
The recent reauthorization of the Prescription Drug User Fee Act, known as PDUFA V, refocuses the program on its original intent of providing timely patient access to life-saving medicines. If implemented successfully, PDUFA V will enhance FDA’s regulatory science capacity and encourage future innovation while strengthening the agency’s high safety standards.
Safeguarding public health
Our industry’s ongoing partnership with the FDA ensures a safe and effective drug supply for the American public. The pharmaceutical industry has long worked to prevent drug shortages in advance, and will continue to work closely with the FDA to prevent manufacturing disruptions. Manufacturers have stepped up the voluntary reporting of anticipated events that might lead to drug shortages, and according to the FDA, in 2011, this early notification helped prevent 195 shortages.
Keeping our drug supply secure
Although America’s pharmaceutical supply remains the safest in the world, no country is immune to the global threat of counterfeit medicines. The most common means for counterfeit drugs to enter the United States is through purchases made on illegal online pharmacy websites operated by criminals in countries with acknowledged counterfeiting problems. The pharmaceutical industry has taken the lead in protecting the public from dangerous counterfeit medicine through initiatives like the VIPPS accreditation program.
Illegal importation of pharmaceuticals remains a serious risk to the health and safety of U.S. citizens. Contamination and improper labeling can lead to dangerous health consequences. As part of its ongoing commitment to safety, the pharmaceutical industry has taken a leading role in prescription assistance through the creation of the Partnership for Prescription Assistance (PPA). By helping millions of uninsured and underinsured Americans afford their prescription medications, PPA reduces the likelihood patients will seek out riskier imports.
The biopharmaceutical industry has also turned to technology to protect the nation’s drug supply chain. PhRMA joins many in the industry in advocating the adoption of tracing systems to keep counterfeit and illegally imported medicines from infiltrating our closed supply.
Preventing prescription drug abuse
The proper use of medicines is another critical element of patient safety. Innovative medicines can extend and enhance patient lives, but they are approved as safe only when taken as directed. Prescription drug abuse remains a problem, and reducing abuse is a high priority for PhRMA and its member companies.
Protecting our environment
Promoting the prompt and safe disposal of unused medicines is an important component to reducing drug abuse as well as protecting our environment. PhRMA is proud of our industry’s work to reduce its environmental footprint. We will continue to collaborate with our partners on programs like the SMARxT Disposal Program and America’s Medicine Chest Challenge to educate the public on responsible drug use and disposal.