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.
During the GPhA 2013 Fall Technical Conference the audience asked a number of questions about important issues relevant to the generic pharmaceutical industry. Click here for a list of questions that were not answered during the conference due to time constraints. Several additional questions were also submitted to the agency as a part of the Docket No. FDA–2012-D-0880-0006, Draft Guidance for Industry Generic Drug User Fee Amendments of 2012: Questions and Answers. Click here and here to read GPhA’s submissions to the GDUFA Q&A docket. Additional questions were also submitted to Docket No. FDA-2012-D-0938-0002; Draft Guidance for Industry; Availability: Abbreviated New Drug Applications; Stability Testing of Drug Substances and Products, Questions and Answers. Click here and here to read GPhA’s submissions to the Stability Q&A docket.
Below are issues on which GPhA and its member companies are active. For consolidated information, download our Annual Report.
Please visit the Biosimilars Council, a division of GPhA, for the most current information and policy positions on biosimilar products.
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.
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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.
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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.
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International Trade Agreements
The Trans-Pacific Partnership (TPP) is a trade agreement currently being negotiated between Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, U.S. and Vietnam. Aside from World Trade Organization (WTO) agreements, TPP would be unprecedented in size and scope. It covers 12 Pacific Rim nations with nearly 40% of global GDP, 35% of trade volume and 800 million inhabitants and is designed to expand beyond its original signatories. In addition to a tariff schedule with some 11,000 tariff lines, TPP sets rules on such issues as competition, services, customs, e-commerce, environment, government procurement, investment, labor, rules of origin, state-owned enterprises and intellectual property.
• International trade agreements should support consumer access and promote competition. In order to achieve this, trade agreements should maintain a reasonable balance between protecting intellectual property (IP) that incentivizes innovation of new medicines and enabling access to more affordable generics.
• The U.S. generic pharmaceutical industry supports trade agreements. In fact, its future depends on the possibility of selling safe and effective medicines in other nations. GPhA is deeply concerned that TPP will raise barriers to entry for generic medicines and biosimilars and hinder global access to more affordable medicines. Further, some of its provisions could result in changes to U.S. law, increasing healthcare expenses and the deficit.
• GPhA strongly supported the Peru, Colombia and Panama Free Trade Agreements (FTAs) because they reflected a balanced approach to promoting exports by both the originator and generic pharmaceutical industries. These agreements are based on the May 10th Agreement, also known as the New Trade Policy – a 2007 bipartisan agreement between the Bush Administration and Congress. This successful policy strikes a balance between protecting IP rights and promoting access to generic medicines. GPhA strongly supports the May 10th Agreement as the standard for IP provisions in the TPP.
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Generic Drug Labeling
Patient safety is the foremost concern of generic drug manufacturers. That is why generic drug companies proactively participate with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling to ensure doctors and patients have access to the most current information.
Currently, generic medicines are required by law to have the same labels as their brand counterparts. When medicines have the same label, it reassures patients and health professionals that these medicines are proven safe and effective.
Indeed, the safety and sameness of FDA-approved generic drugs is the foundation for their widespread acceptance by doctors and patients alike – generic medicines are 84 percent of U.S. prescriptions, exemplifying the high consumer confidence and more affordable choice that these medicines provide.
On November 13, 2013 the FDA released a proposed rule on labeling changes for approved medicines. The rule takes an unprecedented approach to label changes for generic pharmaceuticals. In its current form, the Proposed Rule would increase healthcare costs for consumers and government payers and lead to vast unintended consequences.
A workable solution is within reach. Together, we can establish a process that does not pose risk to patients and does not upend the balance responsible for 30 years of lower health costs and safe generic medicines.
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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.
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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.
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Patients, consumers and health professionals can be assured that FDA approved generic drugs have met rigid standards. To gain FDA approval, a generic drug must:
- Contain the same active ingredients as its brand counterpart
- Be identical in strength, dosage form and route of administration
- Have the same use indications
- Be bioequivalent
- Meet the same batch requirements for identity, strength, purity and quality
- Be manufactured under the same strict standards of FDA good manufacturing practice regulations for innovator product
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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.
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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.
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Patient safety is a top priority of GPhA and its Biosimilars Council. Our members strongly support FDA-mandated Risk Evaluation and Mitigation Strategies (REMS), patient safety programs that serve a clear public health purpose – ensuring that the benefits of a drug outweigh its safety risks.
Congress, the FDA and others have repeatedly raised concerns that these programs are not being used as intended. Certain brand drug companies continue to exploit regulatory loopholes in REMS programs, blocking patient access and delaying market entry of generics and biosimilars in order to preserve their market share for as long as possible.
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Preventing Drug Abuse
Patient safety is a top priority for the generic drug industry and GPhA is strongly committed to curbing misuse of prescription medication. Any medicine could pose health risks if not used as directed by a health provider. It is a public health and patient safety imperative that patients take medicines as prescribed and adhere to the instructions of their doctor, pharmacist or healthcare provider. GPhA and its members support local, state and nationwide efforts to limit drug abuse. Prescription adherence, safe storage and proper disposal help prevent abuse and ensure that patients get the full value of safe, effective and more affordable generic drugs.
GPhA and its members support education for prescribers and providers, and partner with leading national organizations dedicated to promoting public health and preventing abuse. It is important that any effort to minimize drug abuse balances the need to ensure access to medicines for patients who need them.
What is GPhA doing to curb prescription drug abuse?
- GPhA supports the Community Anti-Drug Coalitions of America (CADCA), the national membership organization representing over 5,000 coalitions and affiliates working to make America’s communities safe, healthy and drug-free.
- GPhA is a member of the National Council on Patient Education and Information (NCPIE) and supports its many prescription drug abuse prevention programs including:
- GPhA supports Prescription Drug Monitoring Programs (PDMP) administered by state and local health officials across the country to reduce prescription drug abuse and diversion. The association also supports improving the effectiveness of PDMPs by increasing interoperability and standardization.
- GPhA supports proper disposal of unused or unwanted prescription drugs through U.S. Drug Enforcement Agency Take Back days.
GPhA supports initiatives to assist physicians and other prescribers in the proper prescribing of prescription drugs, particularlyopioids. This includes the five recommendations of the American Medical Association’s Task Force to Reduce Opioid Abuse:
- Register and use your state prescription drug monitoring program to check your patient's prescription history.
- Educate yourself on managing pain and promoting safe, responsible opioid prescribing.
- Support overdose prevention measures, such as increased access to naloxone.
- Reduce the stigma of substance use disorder and enhance access to treatment.
- Ensure patients in pain aren't stigmatized and can receive comprehensive treatment
How do generic manufacturers prevent misuse of their products?
In addition to the measures characterized above, generic drug manufacturers have and continue to develop and market medicines, such as opioids for pain management, with abuse deterrent formulations (ADF). Abuse-deterrent technology makes it harder to misuse medicines by crushing tablets for snorting or further dissolving products with intent to inject the contents. As the Food and Drug Administration (FDA) notes, this does not mean the product is impossible to abuse or that these properties necessarily prevent addiction, overdose or death.
It is important to note that FDA approved generic products with ADF are just as abuse deterrent as their brand counterparts. Additionally, GPhA will continue to work with FDA on draft guidance on generic ADF products. In discussing ADF principles with FDA, GPhA:
- Encourages FDA to spur innovation by drug makers in developing ADF of prescription opioids. However, requiring a specific type of ADF technology – rather than having the determination based on scientific results – will stifle and hamper these much-needed creative solutions.
- Believes that FDA’s determination of whether a generic prescription opioid receives the ADF labeling should not be based on whether the generic has an identical ADF technology.
Four Simple Steps to Getting the Most Value from Your Generic Medicines
As brand and specialty drug costs soar, it’s more important than ever for you as a patient to get the full value of your safe, effective and more affordable generic drugs.
Choose Generic: Make sure to ask your provider or pharmacist if a generic version of the medicine you need is available.
Adhere to Your Treatment Regimen: Always use medicines as directed by your healthcare provider.
Store Your Medicines Safely: Keep your prescription drugs in a place that is cool and dry, since heat and humidity can damage medicines. If there are children in your household and/or you are storing controlled substances prescribed for you, a locked storage area is a good idea to promote safety and prevent misuse.
Follow Safe, Easy Disposal Practices: In-home disposal is the fastest, safest and most convenient way to avoid misuse. The FDA, the Environmental Protection Agency, and the White House Office of National Drug Control Policy also support in-home disposal. Avoid pouring medicines down the drain unless instructed by your healthcare provider.
For more information visit www.safemedsdisposal.org
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What is GDUFA?
GDUFA is a historic achievement for both FDA and the generic pharmaceutical industry. GPhA and its members share and fully support GDUFA objectives with 100 percent industry generated funds.
The three major goals of GDUFA are:
Safety. Ensure that foreign or domestic companies who participate in the U.S. generic drug system are held to consistent high-quality standards with biennial inspections.
Access. Speed the availability of low cost, high quality generic drugs by bringing greater predictability and timeliness to the review times for ANDAs.
Transparency. Enhance FDA’s ability to protect Americans in the complex global supply environment by requiring the identification and registration of all facilities involved in manufacturing of generics and their active ingredients.
Please explore the resources under the Quick Links bar to access the latest available GDUFA-related materials and learn more about the collaborative effort by the FDA. Together, we will continue working to provide timely access to safe, more affordable generic medicines.
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