International advisory vs. Manila: Mayor Lim, Vice Mayor Moreno; Secretary Puno of the Philippine Department of Interior and Local Government.
There is evidence that my letters addressed, to said officials, reached their offices. However, despite R.A. 6713 which said persons are supposed to obey,
they did not provide me with prompt, courteous, satisfactory, service.
The following statement is attributed to said Lim: "The law applies to all, otherwise, none at all.
My letters to said Puno contained complaints vs. said Lim.

I received a letter from a source identified as the Chief of Staff of said Lim: "Security lapses at shopping malls are not the concern of the City government, being
private entities." Does said statement mean that if persons are injured or killed due to security lapses in private entities their injuries or deaths are also not the concern of the City government of Manila?


Facts and Myths about Generic Drugs
http://www.fda.gov


Today, 7 in 10 prescriptions filled in the United States are for generic drugs. This fact sheet explains how generic drugs are made and approved and debunks some common myths about these products.

FACT: FDA requires generic drugs to have the same quality and performance as the 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. 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 puts limits on how much variability in composition or performance of a drug is acceptable.
* Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name (or reference) product. Generic drugs do not need to contain the same inactive ingredients as the brand product.
* Through review of bioequivalence data, FDA assures that the generic product will perform the same as its respective brand name (or reference) product. This standard applies to all generic drugs, whether immediate or controlled release.
* A generic drug must be shown to be bioequivalent to the reference drug; that is, it must be shown to give blood levels that are very similar to those of the reference product. If blood levels are the same, the therapeutic effect will be the same. In that case, there is no need to carry out a clinical effectiveness study and they are not required.
* 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 innovator brand name product. In fact, many generic drugs are made in the same plants as innovator brand name drug products.
* If an innovator of a brand name drug switches drug production to an alternative manufacturing site, or they change formulation of their brand name drug, these companies are held to the same rigorous manufacturing requirements as those that apply to generic drug companies.

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

* A recent 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. [Kesselheim et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21)2514-2526].

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% lower than the brand name product.

* An IMS National Prescription Audit shows that a typical formulary now charges $6 for generic medications, $29 for preferred branded drugs, and $40 or more for non-preferred branded drugs. [Aitken et al. Prescription drug spending trends in the United States: looking beyond the turning point. Health Aff (Millwood). 2009;28(1):w151-60].
* Independent research has shown that total prescription drug expenditures in the United States only increased by 4.0% from 2006 to 2007, with total spending rising from $276 billion to $287 billion. This is a sharp decrease from the 8.9% growth rate observed in prescription drug expenditures in 2006. One factor cited as a reason for the slowdown is an increase in availability and use of generic drugs [Hoffman et al. Projecting future drug expenditures--2009. Am J Health Syst Pharm. 2009;66(3):237-57].

Recently, misinformation in the media has raised concerns over generic drugs. Below are some common myths in circulation.


MYTH: People who are switched to a generic drug are risking treatment failure.

FACT: There is no evidence for this claim. Treatment failures can and do occur when taking generic or brand name drugs. If someone is switched to a generic drug around the time they are relapsing, they may attribute the problem to the switch.

* Many people who have recovered from major depression have a relapse despite continued treatment. These relapses have been shown in trials of long-term therapy. [Byrne and Rothschild. Loss of antidepressant efficacy during maintenance therapy: possible mechanisms and treatments. J Clin Psychiatry. 1998;59(6):279-88].
* Many people who are on a seizure medications will re-experience a seizure despite continued treatment on a single drug. The likelihood of re-experiencing a seizure, despite staying with the same drug product, goes up with time. [Brodie et al. Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy. Neurology. 2007;68(6):402-8].
* A percentage of people will re-experience gastric ulcers, despite an initial, positive response to and continued treatment with prescription strength antacids (cimetidine tablets; http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=8131#nlm34067-9).

MYTH: Generic drugs cost less because they are inferior to brand name drugs.

FACT: Generic manufacturers are able to sell their products for lower prices, not because the products are of lesser quality, but because generic manufacturers generally do not engage in costly advertising, marketing and promotion, or significant research and development.

* When a brand name drug comes off patent and generic drugs are permitted to compete with the brand name drug, the generic products compete by offering lower prices. Unlike the manufacturers of brand name drugs, generic drug companies do not have significant expenses to recoup for advertising, marketing and promotion, or research and development activities.

MYTH: There are quality problems with generic drug manufacturing. A recent recall of generic digoxin (called Digitek) shows that generic drugs put patients at risk.



MYTH: Brand name drugs are safer than generic drugs.

FACT: FDA receives very few reports of adverse events about specific generic drugs. Most reports of adverse events are related to side effects of the drug ingredient itself.

* The monitoring of postmarket 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. In most cases, reports of adverse events generally describe a known reaction to the active drug ingredient.
Page Last Updated: 07/10/2009
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