Here’s the thing though. It does not matter how many voices are heard, we are up against the FDA, okay. They do not care about me nor you. They do not give out information, there is a reason why all these “generic unequivalents” are allowed to be manufactured in countries that we infiltrate “weapons of mass destruction” and serene gas children for oil for.
People on these threads–let’s stop preaching to the choir. The last thing the middle east needs is another proprietary resource blown up, so stop calling them. Let’s focus on the individuals responsible for Okaying the non-regulation of our generic medications without sounding like crackheads. Let’s outsmart them and claim we all take it for narcolepsy which furthermore puts public safety and our healthcare system at risk…thoughts anyone? Read on…
SO, for you all I have taken time to research some real information:
FDA HELPING SMALL BUSINESSES GET BIG RESULTS.
Read up on CDER SBIA and what their “roles” are inside the FDA as the highest ranking officials working solely on generic medication and sharing the wealth to help economies?
The NEW YORK TIMES wrote this last year y’all, and moderators—I AM QUOTING…
You all want some answers on your insurance questions about them making us take brand/generics…Read this article just from 4/2018:
• Aug. 6, 2017
This article was written through collaboration between The New York Times and ProPublica, the independent, nonprofit investigative journalism organization.
It’s standard advice for consumers: If you are prescribed a medicine, always ask if there is a cheaper generic.
Nathan Taylor, a 3-D animator who lives outside Houston, has tried to do that with all his medications. But when he fills his monthly prescription for Adderall XR to treat his attention-deficit disorder, his insurance company refuses to cover the generic. Instead, he must make a co-payment of $90 a month for the brand-name version. By comparison, he pays $10 or less each month for the five generic medications he also takes.
“It just befuddles me that they would do that,” said Mr. Taylor, 41.
A spokesman for his insurer, Humana, did not respond to multiple emails and phone calls requesting comment.
With each visit to the pharmacy, Mr. Taylor enters the upside-down world of prescription drugs, where conventional wisdom about how to lower drug costs is often wrong.
Consumers have grown accustomed to being told by insurers — and middlemen known as pharmacy benefit managers — that they must give up their brand-name drugs in favor of cheaper generics. But some are finding the opposite is true, as pharmaceutical companies squeeze the last profits from products that are facing cheaper generic competition.
Out of public view, corporations are cutting deals that give consumers little choice but to buy brand-name drugs — and sometimes pay more at the pharmacy counter than they would for generics.
The practice is not easy to track, and has been going on sporadically for years. But several clues suggest it is becoming more common.
In recent months, some insurers and benefit managers have insisted that patients forgo generics and buy brand-name drugs such as the cholesterol treatment Zetia, the stroke-prevention drug Aggrenox and the pain-relieving gel Voltaren, along with about a dozen others, according to memos and prescription drug claims that pharmacies shared with ProPublica and The New York Times. At the same time, consumers are sounding off on social media.
Now it appears the practice is spreading to biosimilars, the competitors for expensive, complex biologic drugs that are beginning to arrive on the market.
Consumers have become increasingly angry over what they pay for drugs, and that outrage has caught the attention of lawmakers from both parties. Democrats have identified lowering drug prices as a pillar of their economic agenda, and President Trump has raised the issue repeatedly. But for now, solutions have proved elusive.
The continued success of the brand-name drug Adderall XR, long after generic competitors arrived on the market, is a case in point.
Dr. Lawrence Diller, a behavioral pediatrician in Walnut Creek, Calif., said he began noticing “very odd things” going on with Adderall XR and other attention-deficit drugs about two years ago. He began receiving faxes from pharmacies telling him that he had to specify that patients required brand-name versions of the drugs.
He had been practicing for 40 years, but until then had never had a pharmacy tell him that he had to prescribe a brand-name drug instead of a generic.
“It’s Alice-in-Wonderland time in the drug world,” he said.
Some insurers require members to have prescriptions filled with brand-name drugs and do not charge them more than for generics. But 29 percent of Americans with health insurance paid for by their employer have a high-deductible insurance plan. They acutely feel the cost difference between branded and generic drugs because they often have to pick up the full sticker price of medications until they have paid out thousands of dollars.
Naomi Freundlich, a Brooklyn writer, had been buying the generic version of Adderall XR for two years to treat her son’s attention-deficit hyperactivity disorder. Her family had a $3,000 annual deductible, and the relatively lower price helped keep medical costs down.
Then, in 2014, her pharmacist told her that her insurance plan would cover only the brand-name drug, which cost her family some $50 more a month than the generic. If she paid for the generic herself, it would not have counted toward her deductible. Ms. Freundlich complained to her insurer, UnitedHealthcare, but could not get a clear answer.
“It’s hard to explain because it doesn’t really make sense,” she said.
UnitedHealthcare has continued to favor Adderall XR and certain other brand-name drugs over generics, according to claimsprovided by independent pharmacists and reviewed by ProPublica and The Times. The insurer also recently told health providers that it preferred Remicade, the expensive rheumatoid arthritis drug made by Johnson & Johnson, over biosimilars that have a lower list price and are just beginning to come on the market.
A spokesman for UnitedHealthcare, Matthew N. Wiggin, said the insurer does at times prefer brand-name drugs. “By providing access to these drugs at a lower cost, we are able to improve affordability for our customers and members,” he said in an email.
Asked whether consumers sometimes ended up paying more because of these choices, he said pharmacies and doctors could seek an exemption from the insurer if they wanted the generic instead. Several patients said they had not been told of that option.
Shire, the maker of Adderall XR, and some other brand-name drug manufacturers are no longer content to allow sales of their products to plummet when generic competitors arrive on the market. Instead, they are negotiating deals with insurers and pharmacy benefit managers to give priority to their versions. Consumers are given no details about these deals.
A Shire spokeswoman said the company had been able to hold on to market share for Adderall XR by offering insurers and government programs prices that are competitive with those of generic manufacturers.
Adderall XR, the long-acting version of Shire’s popular treatment Adderall, had for years been the company’s top-selling product, bringing in $1.1 billion in sales in 2008, about one-third of its revenue that year.
But mindful that its blockbuster could soon face generic competition, Shire acted aggressively to protect its franchise.
First, in the mid-2000s, Shire sued generic drug companies to block them from bringing cheaper copies to the market, alleging patent infringement. Then, it made deals with two makers of generic drugs to sell authorized copies of its drug, a tactic in which the branded manufacturer supplies its product in exchange for a share of royalties. Those agreements soured after the two companies, Teva Pharmaceuticals and Impax Laboratories, accused Shire of not playing fair by failing to supply them with enough pills to compete in the marketplace. More lawsuits ensued, followed by settlements.
Then, a few years ago, Shire tried a new tactic: giving ever-larger discounts to pharmacy benefit managers and insurers for preferential treatment over the generics. That did not mean lowering the list price of the drug, but rather negotiating rebates that were paid not to the patients but to insurers and middlemen such as CVS Caremark.
Benefit managers and insurers have been passionate advocates of generic drugs, arguing that the cheaper products save patients and their employers billions of dollars. Indeed, generic drugs have come to dominate the market, and today account for nearly 90 percent of all prescriptions filled in the United States.
Shire has managed to hold on to a much larger share of the market through its deals than most companies do when their drugs come off patent and face generic competition.
Adderall XR, the brand-name version of extended-release mixed amphetamine salts, accounted for 29 percent of the 13.1 million prescriptions for the drug in 2016, according to QuintilesIMS, a health information company that purchases the data from pharmacies and sells it to clients that include drug companies. The average market share of brand-name products dwindles to less than 6 percent two years after the first generic competitor arrives, according to QuintilesIMS.
The list price of Adderall XR has remained $7.12 per pill since mid-2012. But according to data from SSR Health, a research firm that tracks drug prices, the portion that Shire keeps has steadily declined.
In the first quarter of 2017, SSR estimated that Shire kept only $1.73, down from $2.93 per pill in the first quarter of 2013. Shire does not break out how much it pays to each middleman in the system, from distributors to pharmacy benefit managers.
But Ryan Baum, an analyst at SSR Health, said it was clear that Shire’s declining share of the list price reflected “just a really aggressive instance of trying to hang on.”
“It’s irrefutable, really,” he added.
In contrast, the generics cost as low as $3.89 per pill, but that does not include unspecified concessions that generic makers offer to pharmacies and distributors, according to Truven Health Analytics, another research firm that tracks the prices wholesalers pay for drugs.
A spokeswoman for Shire, Gwendolyn Fisher, said that while Shire did not make decisions about how much patients paid in out-of-pocket costs, “Shire is helping to deliver cost savings to the system and greater patient access to an important medicine.”
If we want to be heard we need to bombard these people:
-Christine Baeder, senior vice president for customer and marketing operations at Teva
-Brenda Stodart, Pharm.D. Captain, United States Public Health Service, Program Director at the FDA’s CDER Small Business and Industry Assistance Program, Division of Drug Information
-Renu Lal –CONNECT WITH HER VIA LINKED IN. YEP SHE IS MIDDLE EASTERN:
Pharmacist in FDA’s Division of Drug Information – Small Business and Industry Assistance
Raleigh-Durham, North Carolina Area
CDER Small Business and Industry Assistance
CDER Small Business and Industry Assistance
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993
Brenda Stodart, Pharm.D., Center for Drug Evaluation and Research, 301-796-6707, CDERSmallBusiness@fda.hhs.gov.
They claim this is what they do; written by Miss Stoddart, herself:
By: Brenda Stodart, Pharm.D., and Renu Lal, Pharm. D.
It is well known that small business is vital to the success of the American economy. Less known, though, is how instrumental it has been to the growth and innovation in drug development. We may think of the pharmaceutical industry in terms of giant corporations, but the fact is that there are hundreds of small firms – with very few employees – that are developing many of the important drugs that we use every day. FDA defines a small business as one with fewer than 500 employees (including employees of affiliates), but many are much smaller. Industry sources indicate that, over the past decade or so, more than half of the novel drugs (i.e., those not previously marketed in the United States) developed in this country and approved by FDA, have been developed by small companies. Small companies also impact the generic drug industry creating market choice, competition, and increased access. According to FDA data, of the 2,176 new and generic drug applications submitted to the agency in 2014-2015, at least 639, or about 29 percent, were submitted by firms with fewer than 500 employees. Small companies have certain advantages. They can be nimble with decision-making and can quickly progress with new ideas. A smaller drug development pipeline allows them to focus on a single or few products. But they also have unique challenges. A small workforce tends to require employees to wear multiple hats, as opposed to their larger counterparts who typically employ teams of specialists. And because many small companies are focused on developing one drug at a time, they often operate on a “high reward-high risk” model. There is a smaller margin for error for a small company that has invested all its resources in developing one drug than for a large company that is able to spread its risk across several products it is developing simultaneously. For many years, to help level the playing field, FDA has been assisting small pharmaceutical companies to maximize their opportunities for success. The Generic Drug Forum on April 4-5, 2017, is one example of the work we do to support small businesses. Organized by FDA’s Center for Drug Evaluation and Research Small Business and Industry Assistance (SBIA) staff, representatives from a wide range of pharmaceutical companies will gather to learn about the development, testing, For many years, to help level the playing field, FDA has been assisting small pharmaceutical companies to maximize their opportunities for success. The Generic Drug Forum on April 4-5, 2017, is one example of the work we do to support small businesses. Organized by FDA’s Center for Drug Evaluation and Research Small Business and Industry Assistance (SBIA) staff, representatives from a wide range of pharmaceutical companies will gather to learn about the development, testing, review, and approval of generic drugs. CDER SBIA holds at least four meetings a year as part of a series called the Regulatory Education for Industry (REdI) conferences.review, and approval of generic drugs. CDER SBIA holds at least four meetings a year as part of a series called the Regulatory Education for Industry (REdI) conferences. REdI conferences typically attract significant international attendance (in-person or via webcast). This global reach is important, as about 80 percent of active pharmaceutical ingredients used in U.S-manufactured drugs come from more than 150 different countries. The map below shows the geographic distribution of our most recent REdI conference registrants. Thirty percent of registrants were from outside the U.S., representing 55 countries worldwide.
Many of these companies have never submitted an application for approval to FDA. Whether new or experienced, many are very early in the drug development process. In CDER’s SBIA program, 43 percent of the companies we work with have fewer than 100 employees, and 17 percent have fewer than 10 employees.
Although the mission of CDER SBIA is to help small business, our educational products are available to the entire pharmaceutical industry. In addition to REdI conferences, SBIA also offers webinars with live question and answer sessions by FDA subject matter experts on timely topics of interest to small companies.
SBIA recently held a half-day live webinar, which featured CDER experts from the Office of Pharmaceutical Quality (OPQ) discussing specific microbiology issues. CDER SBIA also provides a variety of helpful resources including a bimonthly electronic newsletter, CDER SBIA Chronicles, an audio podcast, CDERLearn, and online tutorials developed by CDER subject matter experts. We also interact with our constituents through our presentations and exhibits at conferences, and we are always available to help out via phone and e-mail. All slides, webcasts, and documents that we develop to help small companies are posted on the CDER SBIA Learn webpage after the event. REdI conferences and all other SBIA services are available at no cost to all who wish to attend and participate, which is particularly helpful to smaller companies with limited resources.
At a time when quality manufacturing and the safety and effectiveness of drugs in development is as important as ever, CDER understands that providing support to small businesses through education and resources is vital to advancing innovation and protecting public health.
Brenda Stodart, Pharm.D., Captain, United States Public Health Service, is a Program Director at FDA’s CDER Small Business and Industry Assistance Program, Division of Drug Information
Renu Lal, Pharm.D., is a pharmacist at FDA’s Division of Drug Information, CDER Small Business and Industry Assistance Program
I already inmailed Renu Lau to see if she would have a conversation with me through Linked In, but she is based out of North Carolina.
Oh, and get this. I clicked on this link ON THE FDA’s WEBSITE:
CDER Small Business and Industry Assistance (CDER SBIA) Contacts. FDA has representatives who exclusively help small businesses whose products are regulated by FDA. These individuals can provide information that clarifies how agency laws and regulations apply to specific circumstances and suggest methods of meeting those requirements. They can respond to inquiries, conduct or participate in workshops and conferences, or visit your plant, at your request, to offer assistance.
I GOT PAGE NOT FOUND.
HERE IS A COMPLETE LIST OF CONTACTS ON GENERICS:
OFFICE OF GENERIC DRUGS (OGD) DIRECTOR Kathleen (Cook) Uhl, M.D. 240-402-7920 WO 75/Rm. 1692 Deputy Director John Peters, M.D. 240-402-3876 WO 75/Rm. 1690 Administrative Support Assistant Michelle Devlin 240-402-2521 WO 75/Rm. 1695 Clinical Safety Surveillance Staff (CSSS) Director Howard Chazin, M.D. 240-402-8271 WO 75/Rm. 1682 Program Management and Analysis Staff (PMAS) Director Carla Jones, M.S. 301-796-7072 WO 75/Rm. 1653 Communications Staff (CS) Director Kathryn Amatrudo, M.B.A. (Acting) 240-402-0225 WO 75/Rm. 1664 Regulatory Affairs Team (RAT) Supervisory Associate Director Mary J. Dempsey 240-402-7926 WO 75/Rm. 1708 OFFICE OF RESEARCH AND STANDARDS (ORS) Director Robert A. Lionberger, Ph.D. 240-402-7957 WO 75/Rm. 4722 Deputy Director Lei Zhang, Ph.D. 301-796-1635 WO 75/Rm. 4724 Division of Therapeutic Performance (DTP) Director Markham Luke, M.D. 301-796-5556 WO 75/Rm. 4712 Deputy Director Xiaohui (Jeff) Jiang, Ph.D. 240-402-7964 WO 75/Rm. 4716 Division of Quantitative Methods and Modeling (DQMM) Director Liang Zhao, Ph.D. 240-402-4468 WO 75/Rm. 4702 31 | Page Deputy Director Myong-Jin Kim, Ph.D. 301-796-1553 WO 75/Rm. 4682 OFFICE OF BIOEQUIVALENCE (OB) Director Dale Conner, Pharm.D. 240-402-3914 WO 75/Rm. 2718 Deputy Director Trueman Sharp, M.D. 301-796-8191 WO 75/Rm. 2720 Division of Bioequivalence I (DBI) Director Bing Li, Ph.D. 240-402-3916 WO75/Rm. 2674 Deputy Director Utpal Munshi, Ph.D. 240-402-3918 WO 75/Rm. 2682 Division of Bioequivalence II (DBII) Director Ethan Stier, Ph.D. 240-402-3962 WO 75/Rm. 2714 Deputy Director Xiaojian Jiang, Ph.D. 240-402-3964 WO 75/Rm. 2728 Division of Bioequivalence III (DBIII) Director Nilufer Tampal, Ph.D. 240-402-3915 WO 75/ Rm. 2688 Deputy Director April Braddy, Ph.D. 240-402-3917 WO 75/Rm. 2702 Division of Clinical Review Director Sarah Yim, M.D. 301-796-1960 WO 75/Rm. 2522 Deputy Director Daiva Shetty, M.D. 240-402-3866 WO 75/Rm. 2518