Tag Archives: FDA

July 2016 – FDA to Release Announcement Major Generic Drug Labeling Rule

The US Food and Drug Administration (FDA) has now said it will release in July a controversial and major final rule that would allow generic drug companies to update their labels with new safety information like their reference product counterparts have done for almost 30 years.
Background

Under current FDA regulations, generic drug companies with abbreviated new drug applications (ANDAs), unlike companies with new drug applications (NDAs) and biologics license applications (BLAs), cannot independently update product labeling with newly acquired safety information.

That means that when a generic company notices a safety issue that has yet to either crop up or be indicated on its reference product’s label (or the reference product is no longer even produced), the generic company cannot do anything to notify the public of an imminent concern, which raises serious liability issues.

As the proposed rule notes, the current regulatory difference between ANDA holders and NDA and BLA holders means that an individual can bring a product liability action for “failure to warn” against an NDA holder, but generally not an ANDA holder.

As Focus has extensively reported in the past (Read our Regulatory Explainer on the regulation of generic drug labeling), FDA has long been interested in making it easier for all drug companies—not just innovative manufacturers—to update safety labeling.

FDA first unveiled the proposed rule in November 2013, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, but has been deliberating, holding public meetings, and re-opening the federal docket for more comments (the last comment period closed in April).

If finalized, the rule would permit a sponsor of a generic drug to immediately issue a labeling change for any safety-related change, starting a process intended to allow differences to exist between the generic drug, the brand-name reference product and other approved generic drugs on a “temporary basis.”

The labeling change application to FDA would need to contain information such as the basis for the labeling change and available data to support the change, such as adverse event data, published literature or epidemiologic studies.

“The rule may encourage generic drug companies to participate more actively with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements,” FDA says.
New Rule’s Pushback

Without going into much detail, FDA now says it’s “considering several alternatives” described in the more than 23,000 comments submitted to the public docket and considering the financial implications and benefits that would be associated with a final rule, which it plans to release sometime in July, after twice pushing back its release date.

And unlike some in the generic industry, who oppose the rule (to the point of suing FDA) and claim it would expose them to billions of dollars in new legal liabilities, patient advocacy groups are angered by the delay and are pushing for FDA to finalize the rule as quickly as possible.

“The agency should resist pressure from the pharmaceutical industry and finalize a rule that will protect patients,” Dr. Michael Carome, director of the Public Citizen Health Research Group, said in a statement on Thursday. “The agency should move expeditiously to finalize its proposed rule, which will better protect patients by ensuring they have timely access to updated safety information.”

The Generic Pharmaceutical Association, meanwhile, said Thursday that it’s “pleased” FDA will continue to evaluate the wide range of concerns expressed with the agency’s proposal, which would require “generic manufacturers to update labels based on incomplete information without first receiving FDA approval. However, no single manufacturer has access to the full range of available data — the proprietary data from clinical studies or the data held by each individual applicant holder.”

Source : raps.org

What are must be understood about generic medicines

When we buy medicine, maybe you will see two types of drugs, namely branded and generic. Its branded drug prices are much more expensive than generic medicines. Then, what about the quality of generic medicines themselves? of the articles below may help you understand what generic medicines.

Medical Author: Melissa Stoppler, M.D.
Medical Editor: Barbara K. Hecht, Ph.D.

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.

An example of a generic drug, one used for diabetes, is metformin. A brand name for metformin is Glucophage. (Brand names are usually capitalized while generic names are not.) A generic drug, one used for hypertension, is metoprolol, whereas a brand name for the same drug is Lopressor.

Many people become concerned because generic drugs are often substantially cheaper than the brand-name versions. They wonder if the quality and effectiveness have been compromised to make the less expensive products. The FDA (U.S. Food and Drug Administration) requires that generic drugs be as safe and effective as brand-name drugs.

Actually, generic drugs are only cheaper because the manufacturers have not had the expenses of developing and marketing a new drug. When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug. A patent is granted that gives the company that developed the drug an exclusive right to sell the drug as long as the patent is in effect.

As the patent nears expiration, manufacturers can apply to the FDA for permission to make and sell generic versions of the drug; and without the startup costs for development of the drug, other companies can afford to make and sell it more cheaply. When multiple companies begin producing and selling a drug, the competition among them can also drive the price down even further.

So there’s no truth in the myths that generic drugs are manufactured in poorer-quality facilities or are inferior in quality to brand-name drugs. The FDA applies the same standards for all drug manufacturing facilities, and many companies manufacture both brand-name and generic drugs. In fact, the FDA estimates that 50% of generic drug production is by brand-name companies.

Another common misbelief is that generic drugs take longer to work. The FDA requires that generic drugs work as fast and as effectively as the original brand-name products.

Sometimes, generic versions of a drug have different colors, flavors, or combinations of inactive ingredients than the original medications. Trademark laws in the United States do not allow the generic drugs to look exactly like the brand-name preparation, but the active ingredients must be the same in both preparations, ensuring that both have the same medicinal effects.

Reference: Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Generic Drugs: What you need to know. 2009.

Source : http://www.medicinenet.com

Consumption of generic drugs in the US increased

In 2015, the development of generic drugs in the United States increased their consumption. proving that socialization has gone well, and prove the quality of generic drugs the same as the branded drug. Here are some facts about generic drugs:

FACT: FDA requires generic drugs to have the same quality and performance as brand name drugs.  

Generics have the same quality as brand name drugs. When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.
Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs do not need to contain the same inactive ingredients as the brand name product.
The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured.  If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same.
Through review of bioequivalence data, FDA ensures that the generic product performs the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release.
All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products.

FACT:  Research shows that generics work just as well as brand name drugs.

A study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts. There was no evidence that brand name heart drugs worked any better than generic heart drugs.

FACT:    FDA does not allow a 45 percent difference in the effectiveness of the generic drug product.

FDA recently evaluated 2,070 human studies conducted between 1996 and 2007. These studies compared the absorption of brand name and generic drugs into a person’s body. These studies were submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand name was 3.5 percent. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name drug. In fact, there have been studies in which brand name drugs were compared with themselves as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison.
Any generic drug modeled after a single, brand name drug must perform approximately the same in the body as the brand name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product.

FACT: When it comes to price, there is a big difference between generic and brand name drugs. On average, the cost of a generic drug is 80 to 85 percent lower than the brand name product.

In 2010 alone, the use of FDA-approved generics saved $158 billion, an average of $3 billion every week.

FACT: Cheaper does not mean lower quality.

Generic manufacturers are able to sell their products for lower prices because they are not required to repeat the costly clinical trials of new drugs and generally do not pay for costly advertising, marketing, and promotion. In addition, multiple generic companies are often approved to market a single product; this creates competition in the market place, often resulting in lower prices.

FACT: FDA monitors adverse events reports for generic drugs.

The monitoring of adverse events for all drug products, including generic drugs, is one aspect of the overall FDA effort to evaluate the safety of drugs after approval. Many times, reports of adverse events describe a known reaction to the active drug ingredient.
Reports are monitored and investigated, when appropriate. The investigations may lead to changes in how a product (brand name and generic counterparts) is used or manufactured.

FACT:  FDA is actively engaged in making all regulated products – including generic drugs – safer.

FDA is aware that there are reports noting that some people may experience an undesired effect when switching from brand name drug to a generic formulation or from one generic drug to another generic drug. FDA wants to understand what may cause problems with certain formulations if, in fact, they are linked to specific generic products.
FDA is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur. The Agency does not have the resources to perform independent clinical studies and lacks the regulatory authority to require industry to conduct such studies. FDA will continue to investigate these reports to ensure that it has all the facts about these treatment failures and will make recommendations to healthcare professionals and the public if the need arises.

Source : http://www.fda.gov