GENERIC DRUGS AND THE FDA

Generic drugs are replicates of brand-name drugs that come with the same dosage, intended use, effects and side effects, route of administration, risks, safety, and strength as the original (patented) medication. Generic drugs usually are more affordable than the brand name drugs they have patterned after.

This situation occurs for a number of reasons. The first is that the manufacturer of parent medication has spent considerable resources on the research, development, marketing, and promotion of the drug.  Hence these incident costs are usually included in the final price of the drug. On the other hand, generic medicine is developed after its parent drug runs the course of its patent rights, which often spans close to 20 years. For example: co-aleva. A generic drug comes to the market quicker and cheaper because it bypasses most of the base costs/processes associated with producing the parent drug from scratch.

http://groupspaces.com/genericdrugs/

Abbreviated New Drug Application (ANDA)

An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is performs in the same manner as the innovator drug. One way applicants demonstrate that a generic product performs in the same way as the innovator drug is to measure the time it takes the generic drug to reach the bloodstream in healthy volunteers. This demonstration of “bioequivalence” gives  the rate of absorption, or bioavailability, of the generic drug, which can then be compared to that of the innovator drug. To be approved by FDA, the generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm

GENERIC DRUG PRICING AND THE END GAME

Generic drugs have been hailed for the impact they have had on the United States healthcare industry. These group of medicines has ensured that Americans have access to affordable yet qualitative prescription medicine, thereby ensuring improved healthcare delivery.

At its most basic, a generic drug is a copy or replica of a brand-name drug, dispensed with the same dosage, intended use, effects and side effects, route of administration, risks, safety, and strength as the original (patented) drug. Unlike the original medication, a generic drug enters the market at much less a cost compared to that for a brand name due to lower production costs and less stringent regulatory approval routes/paths.

http://www.postpoems.org/authors/artic1904/prose/1060242

The Business Dynamics of Generic and Brand name medication
While the usage statistics for generic drugs means that Americans can access cheaper yet effective medicine, the returns on investment for generic drug production may prove to be its death knell.  Consider that supply chain dynamics for generic drugs give a return on investment of 64 percent, while brand name manufacturers posts as much as /retain over 76 percent of revenue.
While these numbers do not differ to large extents, the impact is telling. This is because of the nature of the two markets involved- generic and brand name.  It is important to note that the brand drug industry is generally controlled by one manufacturer with exclusivity (patent rights for a period of time), while the generic industry follows a multi-competitor model with drug prices decreasing as more competitors enter the marketplace, given the less expensive/arduous path to market entry.
http://www.medicalmingle.com/doctor1970/blog/2018/02/24/generic_drug_supply_chain_and_other_matters

 

Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices

In the United States of America, the figures are more compelling. The FDA continues to propose and enforce regulatory policies that give great traction to the development and deployment of generic medicine. Some of these policies include the following:
1. Improving the efficiency of the generic drug approval process.
2. Providing advisory services to developers of generic medicine in capacity and knowledge building.
3. Creating policies that favor the development of a new class/category of generic drugs referred to as complex drugs.
As a result of these efforts, the US has achieved impressive figures with the use of generic medicine.

https://www.bloglovin.com/@teddyredwings/generic-drugs-savings

This new MAPP does not alter the important Generic Drug User Fee Amendments II review goals or program enhancements, nor does it alter the regulatory requirements for ANDA approval. Rather, the goal of the MAPP is to guide FDA staff to help ensure we work more efficiently with the goal of improving review times.

THE PROS AND CONS OF GENERIC MEDICINE

According to the US Food and Drug Administration (FDA), a generic drug is a medication that is identical, or bioequivalent, to a brand name drug in dosage structure, safety, strength, route of administration, quality, performance characteristics and intended use. In other words, while generic drugs are chemically similar to the original patented medicine, they are often sold for far less. Statistics show that generic drugs save consumers an estimated 8 to 10 billion USD a year at retail pharmacies. The FDA touts generics as the way to go in the provision of qualitative yet affordable medicines to the consuming public.

https://www.minds.com/blog/view/812928478460022784

EXECUTIVE SUMMARY

Health care is a vital service that daily touches the lives of millions of Americans at significant and vulnerable times: birth, illness, and death. In recent decades, technology, pharmaceuticals, and know-how have substantially improved how care is delivered and the prospects for recovery. American markets for innovation in pharmaceuticals and medical devices are second to none. The miracles of modern medicine have become almost commonplace. At its best, American health care is the best in the world.
Notwithstanding these extraordinary achievements, the cost, quality, and accessibility of American health care have become major legislative and policy issues. Substantial increases in the cost of health care have placed considerable stress on federal, state, and household budgets, as well as the employment-based health insurance system. Health care quality varies widely, even after controlling for cost, source of payment, and patient preferences. Many Americans lack health insurance coverage at some point during any given year. The costs of providing uncompensated care are a substantial burden for many health care providers, other consumers, and tax payers.
This Report examines the role of competition in addressing these challenges. The proper role of competition in health care markets has long been debated. For much of our history, federal and state regulators, judges, and academic commentators saw health care as a "special" good to which normal economic forces did not apply. Skepticism about the role of competition in health care continues.
 https://www.justice.gov/atr/executive-summary

Is generic medication as good as name brand?

Brand name drugs are registered under patents, but those patents are limited. When they expire, the drugs and their manufacturing process become “public property”, in a manner of peaking. Other licensed pharmacological companies can then duplicate these drugs under different names. The duplicated copies of these drugs are called generic drugs. They are created to be exactly the same as the name brand originals.

The brand name original of the drug does not just stop being made either; it remains in circulation alongside the generic versions of it.

http://www.imfaceplate.com/Mark1950/is-generic-medication-as-good-as-name-brand

When getting a prescription filled, you might have been asked whether you would prefer the generic alternative. Understanding the differences between generic and brand name medicines can help you make an informed choice.

Are generic medicines the same as brand-name medicines?

In the way they work, yes. In other ways, maybe not.
Every medicine has a brand name, which is given by the pharmaceutical company that markets the drug, and a generic name, the drug’s ‘active ingredient’ that makes it work.
When a medicine with a new active ingredient first appears, it is protected by a patent for several years. The patent is designed to allow the company to make enough profits to recover the money it spent developing the medicine, or on buying the rights to market it.

https://www.healthdirect.gov.au/generic-medicines-vs-brand-name-medicines

BIOAVAILABILITY OF GENERIC DRUGS

Generic drugs are copies made from an already existing template of a particular medication. They do not pass through testing, innovation and approval like the original drugs on which they are based did. They are produced after the patent on an original drug has expired, after which drug manufacturing companies can apply to get approval to produce these drugs at a cheaper rate.

Generic drugs are common because of their availability and relatively cheap cost. The manufacturers do not have to spend money and time on the drug innovation and development, and so they are produced chiefly to be more accessible. This is why most doctors and patients prefer the generic drugs, because they save money.

There are, however, some concerns raised when it comes to the consumption of these drugs. "This is why they have to undergo rigorous testing and approval by the FDA before they can be deemed a safe alternative to a name brand medication".
http://groupspaces.com/BIOAVAILABILITY/

Evaluating the bioavailability and bioequivalence of generic medications.

 By law, the U.S. Food and Drug Administration (FDA) is permitted to approve generic versions of brand-name medications without necessarily requiring that research be conducted to prove them safe and effective, provided that a number of criteria are met. The most important criterion is bioequivalence. Bioavailability refers to the rate and extent to which the active ingredient is absorbed from a drug product. Maximum drug concentration (Cmax) is the parameter used to characterize the absorption rate. The area under the plasma drug concentration-time curve (AUC) is the parameter used to characterize the extent of drug absorption. Bioequivalence means that there is an equivalent rate and extent of absorption of the same active ingredient from two or more drug products. For a generic drug to be approved, both Cmax and AUC must vary only within a certain limited range compared with those for the brand name medication. Information about generic and pharmaceutical alternative drugs can be found in the Orange Book and via Drugs@FDA.

https://www.ncbi.nlm.nih.gov/pubmed/20102127

Generic Drugs Uses and Side Effects

Generic drugs are copies or replicas of brand-name drugs that are dispensed with the same dosage, intended use, effects and side effects, route of administration, risks, safety, and strength as the original (patented) drug. Generic drugs are often substantially cheaper than the brand name drugs they take after.  This happens for a number of reasons. The first is that the manufacturer of parent medication has spent considerable resources on the research, development, marketing, and promotion of the drug.


The said drug is protected by exclusivity and patent rights for a period of time (usually set at 20 years) whereby the original producers of the medicine can recoup the funds invested. Toward the end of the patent expiration, the manufacturer and other producers can apply to develop a generic version of the drug, with incurring the base costs associated with producing such medicine from scratch. https://diigo.com/0bf3y8

 

 What is meant by generic medications?

Generic drugs are deployed under close scrutiny and regulation from government agencies tasked with the responsibility of oversight. A major stipulation for this class of medicines is that generic drugs must contain the same active ingredients as the patented brand name formula of the original manufacturer. In other words, a generic drug must fall within the same bioequivalence for the active ingredients associated with the original formulation. However, there could inconsequential differences in terms of color, form, flavors or a difference in non-active ingredients.

In ensuring fairness to initial manufacturers of medicines, generic drugs are only available after the expiration of the patent rights accorded the brand name formulation. Most countries peg the duration of this protection window at 20 years; although nations like the U.S.A might grant an extension to this window by as much as 5 years.

http://www.medicalmingle.com/doctor1970/blog/2018/02/10/what_is_meant_by_generic_medications

Definition and Classification of Generic Drugs Across the World

The World Health Organization (WHO), during the World Health Assembly in 1975, published a resolution to develop means to assist Member States in formulating national drug policies. Since then, and following the recommendations of the WHO, many countries have developed their own national drug policies. The framework of these recommendations is often considered to be built around improving access to “essential drugs” that in most cases mirror the Essential Medicines List from the WHO, currently in its 18th edition . According to the WHO, this list includes the most efficacious, safe and cost-effective medicines for priority conditions. Most of the drugs included are off-patent and available as generic products, which are often offered at lower prices than the innovator branded product, potentially reducing costs for patients and the healthcare system . The use of generic pharmaceutical products is then promoted, in order to reduce costs and increase access to healthcare . But, despite highlighting the need for rigorous quality and safety assessments for pharmaceutical products in order to achieve these goals, the quality of pharmaceutical products available in the market in many developing countries varies, in part because of the lack of clear and specific requirements for generic pharmaceutical products.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4519628/

Generic drugs and patents

Let's just say a patent is a monopoly right that's usually bestowed on the people or companies that own an invention. This right is given by the Government to ensure that the invention is not copied or used by other people without the inventors knowledge or consent in that country where the patent has been obtained.Whilst protecting the invention, a patent owner is able to exploit and maximize the patent power in many ways. One of the ways includes licensing the patent to third parties for high commercial returns, raising funds for business or even selling the patented invention for a lofty sum of money. A patent usually takes about 20 years from the date of filling the application for the patent before it expires.
https://www.bloglovin.com/@teddyredwings/generic-drugs-patents-464395

BIOAVAILABILITY OF GENERIC DRUGS

Generic drugs are copies made from an already existing template of a particular medication. They do not pass through testing, innovation and approval like the original drugs on which they are based did. They are produced after the patent on an original drug has expired, after which drug manufacturing companies can apply to get approval to produce these drugs at a cheaper rate.
Generic drugs are common because of their availability and relatively cheap cost. The manufacturers do not have to spend money and time on the drug innovation and development, and so they are produced chiefly to be more accessible. This is why most doctors and patients prefer the generic drugs, because they save money.
http://groupspaces.com/medications/item/1160531

Generic Drugs Differences and Benefits

Generic drugs are usually cheaper than their brand name counterparts and that's one of the reasons why people sometimes like to settle for it. Generic medications are designed and structured to function the same way as an approved brand named drug.
 
They work the same way in terms of safety, strength, stability, dosage form, performance characteristics, quality, and route of administration. Both generic drugs and brand name drugs use the same active ingredients and so they have the same benefits and risks. So in essence, a generic medicine is a brand name drug that uses a different name so it's safe to say they work just the same as Brand name medicines.

http://www.postpoems.org/authors/artic1904/prose/1059089

ACOG Committee Opinion No. 375: Brand versus generic oral contraceptives.

Committee on Gynecologic Practice, American College of Obstetricians and Gynecologists¹.

The U.S. Food and Drug Administration considers generic and brand name oral contraceptive (OC) products clinically equivalent and interchangeable. The American College of Obstetricians and Gynecologists supports patient or clinician requests for branded OCs or continuation of the same generic or branded OCs if the request is based on clinical experience or concerns regarding packaging or compliance, or if the branded product is considered a better choice for that individual patient.

https://www.ncbi.nlm.nih.gov/pubmed/17666623