Issues

GPhA focuses on a wide variety of issues that affect the generic industry and works with state and federal lawmakers, the FDA and other stakeholders to ensure that affordable medicines will be available to consumers.

Below are issues on which GPhA and its member companies are active. For consolidated information, download our 2008 Annual Report.

Biosimilars

GPhA applauds Congress for establishing an abbreviated approval pathway for biosimilars and interchangeable biologics as part of the Affordable Care Act (ACA), which became law March 23, 2010. GPhA and its member companies are working hard with the FDA to assure that the new biosimilar pathway is implemented in a manner that encourages development of safe and less-costly biosimilars.

Biologic medicines are often the only lifesaving treatments for the most severe diseases, but their high price tag can keep them out of reach for many patients. The cost of biologics is increasing at a faster annual pace than any other component in health care.

As proven with chemical prescription drugs, biosimilar competition is expected to be the most important opportunity to hold down the cost of biologic medicines. GPhA is working with the FDA to ensure the approval process is workable and provides for timely availability of FDA-approved, safe, effective and less-costly biosimilar medicines.

Drug Disposal/Take Backs

Prescription medications are critical to maintaining health and improving the quality of life for millions of Americans. However, for a variety of reasons, not all of the prescription dispensed to a patient ends up being consumed and the unused drugs often are disposed of improperly. New analytical techniques capable of identifying material concentrations in amounts as little as one-part-per-trillion has enabled the detection of very low trace amounts of pharmaceuticals in water and soil. Reports of the presence of pharmaceutical compounds in the environmental understandably have sparked public concern and have prompted some authorities to consider various “pharmaceutical waste” initiatives. GPhA supports the safe disposal of unused drugs and urges legislators and policymakers to join industry in promoting robust public education campaigns to teach consumers the importance of properly discarding unused medicines.

Drug Shortages

As members of the public who also are affected by shortages, the generic pharmaceutical industry is devoted to working with all stakeholders to minimize current shortages and mitigate factors that could contribute to future shortages. We are acutely aware of the distress caused to patients, families and clinicians by the shortage of critical drugs. Drug shortages represent a complex, multi-faceted issue and our industry has and will continue to work tirelessly to be part of the solution. GPhA is committed to working with the FDA and all stakeholders to minimize current drug shortages and prevent future shortages from occurring. Nothing is more important to our industry than ensuring patients have access to their lifesaving generic medications, and, with a joint effort among all involved, we believe we can make a significant step toward accomplishing this goal.

Free Trade Agreements

Current U.S. intellectual property laws governing the pharmaceutical market have helped maintain an effective balance between protecting intellectual property that incentivizes the innovation of new medicines and supporting access to affordable generic medicine. So that Free Trade Agreements (FTAs) do not disrupt this balance, GPhA believes that the terms of these agreements should not provide more intellectual rights to brand companies than afforded under U.S. law. Correspondingly, FTAs should include provisions that support consumer access to affordable generic medicines. GPhA supports the progress made in recent U.S. trade policy that helps maintain the innovation-access balance. GPhA urges the U.S. Trade Representative to work with Congress to make certain that future FTAs protect this balance.

Medicaid

GPhA participates with federal and state governments to implement policies that promote increased generic use, thereby achieving greater savings. GPhA member companies play a significant role in providing prescription medicines to the nearly 60 million Americans receiving Medicaid benefits. Approximately 65% of all drugs dispensed through the Medicaid program are generic, costing on average 60% less per prescription than the corresponding brand and saving the Medicaid program tens of billions of dollars each year.

Patent Settlements

GPhA vigorously opposes restricting the right of parties in drug patent litigation to settle their disputes out of court. Settling patent cases cuts short lengthy court trials with potential appeals and guarantees that lower cost generic versions of name brand drugs come to market before patents expire. Banning settlements would force companies to continue drawn-out litigation until a court handed down its decision and then allow generic market entry only if the generic company wins the case. Over the past 12 years, generics have won less than 50 percent of the patent cases. The bottom line is clear and convincing: settlements guarantee savings for consumers, the government and healthcare providers; limiting settlements risks these savings by betting that the generic company will always win the patent suit. GPhA is committed to preserving current law, which allows companies to settle patent litigation out of court.

Quality

Science and quality are the cornerstones of the generic pharmaceutical industry. GPhA and its member companies strongly support strict enforcement of the rigorous good manufacturing requirements set by the FDA. Specifically, the generic pharmaceutical industry utilizes a modern, scientific and risk-based pharmaceutical quality system as part of its commitment to excellence. Like the brand industry, generic manufacturers embrace FDA principles set forth in the Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach and the Process Analytical Technology initiative, which help assure product quality through design and performance-based specifications. Members of the generic pharmaceutical sector consistently make substantial investments in manufacturing facilities and their drug testing infrastructure to ensure product integrity, quality assurance and quality control.

State Initiatives

GPhA supports initiatives and policies in states that encourage the use of safe, effective and affordable generic versions of brand name prescription drugs. GPhA opposes all attempts to carve out certain categories of drugs from generic substitution practices. As state legislatures look for ways to rein in health care costs, it is critical for lawmakers take full advantage of FDA-approved generic prescription drugs, which have produced more that $1 trillion in savings to state and federal health care programs over the past decade.

Supply Chain Security

U.S. consumers currently benefit from of the world’s most secure prescription drug supply chain. The Food and Drug Administration (FDA) and the U.S. pharmaceutical industry are exceptionally vigilant against the distribution and sale of counterfeit and adulterated medicines. Filling 80% of the prescriptions in the U.S., the generic pharmaceutical industry is heavily vested in ensuring the security of the U.S. drug supply. GPhA believes that the problem of counterfeit medicines raises a very significant public health concern that must be addressed systemically on a range of levels—from local to global, and throughout the drug supply chain.

User Fees

GPhA and its member companies support full implementation of the generic user fee program (GDUFA) as created by the 2011 Food and Drug Administration Safety and Innovation Act. Under GDUFA, manufacturers of finished dose generic drugs and their active pharmaceutical ingredients will pay to FDA $299 million in user fees each year for fiscal years 2013 through 2017. This money, coupled with appropriations provided each year to FDA’s Office of Generic Drugs, will enable timely facility inspections and generic drug approvals. And because FDA-approved generics can cost up to 80 percent less than their brand name counterparts, GDUFA will expedite access to affordable and therapeutically equivalent medicines for millions of consumers and patients.