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52-576: Title I extends through FY2017 the authority of the FDA, through the authority of the Secretary of Health and Human Services , to collect drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees to support the FDA process for reviewing human drug applications. It requires the FDA to submit annually to the House Committee on Energy and Commerce and

104-552: A cellulose ether hydroxypropyl methylcellulose (HPMC) film coating is used which is free of sugar and potential allergens . Occasionally, other coating materials are used, for example synthetic polymers, shellac , corn protein zein or other polysaccharides. Capsules are coated with gelatin. Enterics control the rate of drug release and determine where the drug will be released in the digestive tract. Materials used for enteric coatings include fatty acids, waxes, shellac, plastics, and plant fibers. Colours are added to improve

156-551: A drug master file fee; (3) an abbreviated new drug application and prior approval supplement filing fee, as well as an additional fee for certain active pharmaceutical ingredient information; and (4) a generic drug facility fee and active pharmaceutical ingredient facility fee. Similarly to Title III, Title IV directs the FDA to assess and collect the following fees related to biosimilar biological products: (1) biosimilar program development fees, encompassing an initial biosimilar development fee, an annual biosimilar development fee, and

208-399: A foreign government if the information alerts the FDA to a potential need for a safety investigation, the information is provided to the FDA voluntarily on the condition that it is not released to the public, and the information is subject to a written agreement between the FDA and the foreign government. It authorizes the FDA to require importers of drugs to provide certain information to allow

260-500: A liquid or a gas either by adsorption or by absorption ) in a dry state. For example, desiccants absorb water, drying out ( desiccating ) the surrounding materials. Sweeteners are added to make the ingredients more palatable, especially in chewable tablets such as antacid or liquids like cough syrup . Sugar can be used to mask unpleasant tastes or smells, but artificial sweeteners tend to be preferred, as natural ones tend to cause tooth decay. In liquid and gel formulations,

312-612: A patient is more likely to adhere to their schedule and therapeutic objectives will also have a better outcome for the patient especially children. Disintegrants expand and dissolve when wet causing the tablet to break apart in the digestive tract , or in specific segments of the digestion process, releasing the active ingredients for absorption . They ensure that when the tablet is in contact with water , it rapidly breaks down into smaller fragments, facilitating dissolution . Examples of disintegrants include: Flavours can be used to mask unpleasant tasting active ingredients and improve

364-476: A reactivation fee; (2) a biosimilar product application and supplement fee; (3) a biosimilar product establishment fee; and (4) a biosimilar product fee. Fees are waived for the first biosimilar application of a small business. Title V makes permanent the Best Pharmaceuticals for Children Act , granting extended market exclusivity for new and already-marketed drugs for the pediatric population, and

416-523: A significant loss or theft of such drug intended for use in the US, or that a drug has been or is being counterfeited and sold in the US, or a drug has been or could be imported into the US. An amendment proposed by John McCain to allow consumers to obtain drugs from Canada was rejected. Title VIII is referred to as the GAIN Act , and was passed to incentivize the development of new antibiotics in response to

468-516: A task force to develop and implement a plan for enhancing the FDA's response to preventing and mitigating drug shortages. It requires the FDA to maintain an up-to-date list of drugs determined to be in shortage, including the name of each drug in shortage, the name of each manufacturer of a drug in shortage, the reason for the shortage, and the estimated duration of the shortage. It amends the Controlled Substances Act to require

520-424: A unique facility identifier of such establishment, and an e-mail address for each excipient manufacturer. It requires the FDA to maintain an electronic database for the purposes of risk-based inspections and to conduct risk-based inspections of registered drug establishments, including inspections for medical devices, and post a report on the FDA website on the number of domestic and foreign establishments registered in

572-427: A unique pathology or physiological condition that no other device is domestically available to treat are exempted from post-marketing approval requirements. Title VII imposes FDA registration requirements for domestic and foreign drug establishments. It expands drug product listing information to include information on drug excipient establishments, including all establishments used in the production of such excipient,

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624-535: Is a level I position in the Executive Schedule , thus earning a salary of US$ 246,400, as of January 2024. Xavier Becerra has served as the 25th United States secretary of health and human services since March 19, 2021, the first person of Latino descent to hold the post. The duties of the secretary revolve around human conditions and concerns in the United States . This includes advising

676-464: Is defined as an antibacterial or antifungal drug intended to treat serious or life-threatening infections. It requires the FDA to establish and maintain a list of pathogens qualifying for the program and makes qualified infectious disease products eligible for priority and fast track review. As of Sept. 2013, the FDA had issued 24 QIDP designations for 16 chemical entities. In response to the GAIN Act,

728-506: The Attorney General to review requests to increase quotas of controlled substances and make a determination within 30 days if a request pertains to a drug in shortage. It allows a hospital that is owned and operated by the same entity and that shares access to databases with drug order information for its patients to repackage a drug in shortage (i.e., divide its volume into smaller amounts) and transfer it to another hospital within

780-488: The Controlled Substances Act . Several proposed amendments were rejected. By 28 yeas to 67 nays, Bingaman Amendment No. 2111, to allegedly provide cost savings by fostering competition among generic pharmaceutical manufacturers and ensuring that anti-competitive "pay-for-delay" settlements between brand-name and generic pharmaceutical manufacturers do not block generic drugs from entering the market. By 46 yeas to 50 nays, Murkowski Amendment No. 2108, to prohibit approval by

832-536: The Food and Drug Administration (FDA) , Centers for Disease Control (CDC) , National Institutes of Health (NIH) , Administration for Children and Families (ACF) and Centers for Medicare & Medicaid Services (CMS) .     Democratic (9)     Republican (15)     Independent (2) Status    Denotes acting HHS Secretary    Nominee for Secretary of Health and Human Services The line of succession for

884-419: The breakthrough therapy designation. It also extends through FY2017 the authorization of appropriations for grants and contracts for the development of drugs for rare diseases and conditions ( orphan drugs ). It directs the FDA to award a priority review voucher to a sponsor of a rare pediatric disease product application, and establish a user fee program for such sponsors. Breakthrough Therapy Designation

936-448: The control substances in order to minimize confounding , reflecting that otherwise, the absence of the active ingredient would not be the only variable involved, because absence of excipient cannot always be assumed not to be a variable. Such studies are called excipient-controlled or vehicle -controlled studies. Adjuvants are added to vaccines to enhance or modify the immune system response to an immunization. An adjuvant may stimulate

988-557: The president on matters of health , welfare , and income security programs. The secretary strives to administer the Department of Health and Human Services to carry out approved programs and make the public aware of the objectives of the department. The Department of Health, Education and Welfare (HEW) was reorganized into a Department of Education and a Department of Health and Human Services (US DHHS) . The Department of Health and Human Services oversees 11 agencies including

1040-513: The FDA announced in Sept. 2012 that they were creating The Antibacterial Drug Development Task Force to assist in developing and revising guidance related to antibacterial drug development . The task force consisted of a multi-disciplinary group of 19 CDER scientists and clinicians who were charged with identifying priority areas and developing and implementing possible solutions to the challenges of antibacterial drug development. Title IX states that

1092-476: The FDA from rejecting an application for approval of a medical device for investigational use on the basis that: (1) the investigation may not support a substantial equivalence or de novo classification determination or approval of the device; (2) the investigation may not meet a requirement, including a data requirement, relating to the approval or clearance of a device; or (3) an additional or different investigation may be necessary to support clearance or approval of

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1144-475: The FDA should apply accelerated approval and fast track provisions to expedite the development of treatments for serious or life-threatening diseases, while maintaining safety and effectiveness standards for such treatments. It requires the FDA, at the request of a drug sponsor, to expedite the review of a drug if the drug treats a serious or life-threatening disease or condition and the drug demonstrates substantial improvement over existing therapies. This created

1196-444: The FDA to assess the risk of importing such drugs and it requires the registration of commercial drug importers with the FDA. It requires the FDA to publish regulations to establish good importer practices that specify the measures an importer shall take to ensure that imported drugs are in compliance. It requires a manufacturer or distributor to notify the FDA if they know that the use of a drug may result in serious injury or death, of

1248-406: The FDA to destroy counterfeit or adulterated imported drug products that have minor monetary value or a reasonable probability of causing serious adverse health consequences or death. It authorizes the FDA to detain drugs found during inspection to be adulterated or misbranded. It exempts the FDA from freedom of information disclosure requirements with respect to information about drugs obtained from

1300-414: The FDA to order post-marketing surveillance for medical devices at the time of their approval or clearance or at any time thereafter and requires device manufacturers to start surveillance not later than 15 months after the date the FDA issues an order. Medical devices for small or unique populations that are created or modified to comply with the order of an individual physician and that are designed to treat

1352-699: The Federal Food, Drug, and Cosmetic Act, the False Claims Act, and other certain laws. Two measures were tabled: an amendment to require manufacturers of dietary supplements to register dietary supplement products with the Food and Drug Administration, and an amendment to amend the Federal Food, Drug, and Cosmetic Act concerning claims about the effects of foods and dietary supplements on health-related conditions and disease, to prohibit employees of

1404-496: The Food and Drug Administration from carrying firearms and making arrests without warrants, and to adjust the mens rea of certain prohibited acts under the Federal Food, Drug, and Cosmetic Act to knowing and willful. Secretary of Health and Human Services The United States secretary of health and human services is the head of the United States Department of Health and Human Services , and serves as

1456-549: The Food and Drug Administration of genetically engineered fish unless the National Oceanic and Atmospheric Administration concurs with such approval. By 43 yeas to 54 nays, McCain Amendment No. 2107, to allow the importation by individuals of safe and affordable drugs from Canada. By 9 yeas to 88 nays, Sanders Amendment No. 2109, to revoke the exclusivity of certain entities that are responsible for violations of

1508-494: The Pediatric Research Equity Act of 2003 for research into pediatric uses for existing drugs. Exclusivity will be granted only upon a written request. It also grants authority to the FDA to extend a deadline for a pediatric drug study. It requires an applicant for a pediatric drug to submit an initial pediatric study plan to the FDA prior to the submission of drug safety assessments. Title VI prohibits

1560-910: The Senate Committee on Health, Education, Labor, and Pensions, a report on the progress of the FDA in achieving the goals of the administration, future plans of the FDA, and the progress of the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research in achieving such goals. The report should include the number of: (1) new drug applications and biologics license applications filed, (2) priority new drug and biologics applications filed, (3) standard efficacy supplements, (4) priority efficacy supplements, (5) applications filed for review under accelerated approval, (6) applications filed for review as fast track products, (7) applications filed for orphan-designated products, and (8) breakthrough designations. Title II extends through FY2017

1612-484: The US in determining whether to approve a drug. It requires the FDA to issue a final determination on any petition filed by a generic drug applicant for determining whether a drug was withdrawn for a safety or effectiveness reason no later than 270 days after the filing of any such petition. It amends the Controlled Substances Act to add as a Schedule I controlled substance any material, compound, mixture, or preparation which contains specified cannabimimetic agents (or

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1664-756: The acceptance that the patient will complete a course of medication. Flavourings may be natural (e.g. fruit extract) or artificial. For example, to improve: Glidants are used to promote powder flow by reducing interparticle friction and cohesion. These are used in combination with lubricants as they have no ability to reduce wall friction. Examples include silica gel , fumed silica , talc , and magnesium carbonate . However, some silica gel glidants such as Syloid(R) 244 FP and Syloid(R) XDP are multi-functional and offer several other performance benefits in addition to reducing interparticle friction including moisture resistance, taste, marketing, etc. Lubricants prevent ingredients from clumping together and from sticking to

1716-498: The appearance of a formulation. Colour consistency is important as it allows easy identification of a medication. Furthermore, colours often improve the aesthetic look and feel of medications. Small amounts of colouring agents are easily processed by the body, although rare reactions are known, notably to tartrazine . Commonly, titanium oxide is used as a colouring agent to produce the popular opaque colours along with azo dyes for other colors. By increasing these organoleptic properties

1768-434: The authority of the FDA to assess and collect fees for medical device applications and submissions. It authorizes the FDA to grant a full or partial waiver of medical device user fees if the FDA finds that the waiver is in the interest of public health. Title III directs the FDA to assess and collect fees related to generic drugs : (1) a one-time backlog fee for abbreviated new drug applications pending on October 1, 2012; (2)

1820-440: The device. It requires the FDA to establish a program to assess information relating to recalls of medical devices, and document the basis for termination by the FDA of a device recall. It authorizes the FDA to prohibit the sponsor of an investigation of the effectiveness of a medical device from conducting such investigation (issuing a clinical hold) if the FDA makes a determination that the device represents an unreasonable risk to

1872-413: The dosage form, and compatibility with the active ingredient. Virtually all marketed drugs contain excipients, and final drug formulations commonly contain more excipient than active ingredient. Pharmaceutical regulations and standards mandate the identification and safety assessment of all ingredients in drugs, including their chemical decomposition products. Novel excipients can sometimes be patented, or

1924-597: The drug products, it may also negatively impact the product quality. For example, extended mixing of lubricants during blending may results in delayed dissolution and softer tablets, which is often referred to as "over-lubrication". Therefore, optimizing lubrication time is critical during pharmaceutical development. There are three roles identified with lubricants as follows: There are two major types of lubricants: Some typical preservatives used in pharmaceutical formulations are Sorbents are used for tablet/capsule moisture-proofing by limited fluid sorbing (taking up of

1976-419: The expected shelf life); or to add bulk to solid formulations that have small amounts of potent active ingredients (in that context, they are often referred to as "bulking agents", "fillers", or "diluents"). During the manufacturing process, excipients can improve the handling of active substances and facilitate powder flow. The choice of excipients depends on factors such as the intended route of administration,

2028-550: The growing threat of antibiotic resistance and a lack of antibiotic products in pharmaceutical manufacturers' pipelines. It extends the exclusivity period for qualified infectious disease products by five years. The extra five years of market protection is in addition to any other existing exclusivity, including those available under the Hatch-Waxman Act (3 to 5 years), orphan drug (7 years), or pediatric exclusivity (6 months). A "qualified infectious disease product"

2080-406: The immune system to respond more vigorously to a vaccine, which leads to more robust immunity in the recipient. Antiadherents reduce the adhesion between the powder ( granules ) and the punch faces and thus prevent sticking to tablet punches by offering a non-stick surface . They are also used to help protect tablets from sticking. The most commonly used is magnesium stearate . Binders hold

2132-425: The ingredients in a tablet together. Binders ensure that tablets and granules can be formed with required mechanical strength, and give volume to low active dose tablets. Binders are usually: Binders are classified according to their application: Tablet coatings protect tablet ingredients from deterioration by moisture in the air and make large or unpleasant-tasting tablets easier to swallow. For most coated tablets,

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2184-601: The new United States Department of Education . Patricia Roberts Harris headed the department before and after it was renamed. Nominations to the office of Secretary of HHS are referred to the Health, Education, Labor and Pensions Committee and the United States Senate Committee on Finance , which has jurisdiction over Medicare and Medicaid, before confirmation is considered by the full United States Senate . Secretary of Health and Human Services

2236-482: The previous fiscal year, the number of inspections of such establishments, and the percentage of the FDA budget used to fund such inspections. It requires an establishment that is engaged in the manufacture or preparation of a drug to provide the FDA with records or other information in advance of an inspection. A drug is deemed adulterated if the establishment in which such drug was manufactured, processed, packed, or held does not comply with inspections. It authorizes

2288-614: The principal advisor to the president of the United States on all health matters. The secretary is a member of the United States Cabinet . The office was formerly Secretary of Health, Education, and Welfare. In 1980, the Department of Health, Education, and Welfare was renamed the Department of Health and Human Services, and its education functions and Rehabilitation Services Administration were transferred to

2340-400: The prohibition on profit for medical devices that have been granted humanitarian device exemptions to include devices intended for use in adults, if such a device is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients, or that occurs in such numbers that the device's development is impossible, highly impracticable, or unsafe. It authorizes

2392-403: The safety of the participants of the clinical trial. It authorizes the FDA to classify certain new medical devices without first issuing a determination that such devices are not substantially equivalent to existing devices and change the classification of a medical device based upon new information about such device by administrative order instead of by regulation. It expands the exemption from

2444-444: The salts, isomers, or salts of isomers thereof), and specified additional hallucinogenic substances. The Synthetic Drug Abuse Prevention Act of 2012 bans synthetic compounds commonly found in synthetic marijuana ("K2" or "Spice"), synthetic cathinones (" bath salts ") MDPV and methylone , as well as hallucinogenic drugs 2C-C , 2C-D , 2C-E , 2C-I . 2C-H , 2C-N , 2C-P , and 2C-T-2 by placing them under Schedule I of

2496-430: The same health system without incurring otherwise applicable FDA registration requirements. Title XI includes several provisions. It provides for expanded FDA regulation of medical gases. It requires the FDA to work with other regulatory authorities and international organizations to encourage uniform clinical trial standards for medical products worldwide, and accept data from clinical investigations conducted outside of

2548-405: The secretary of health and human services is as follows: Excipient An excipient is a substance formulated alongside the active ingredient of a medication . They may be used to enhance the active ingredient’s therapeutic properties; to facilitate drug absorption; to reduce viscosity; to enhance solubility; to improve long-term stabilization (preventing denaturation and aggregation during

2600-595: The specific formulation can be kept as a trade secret to prevent competitors from duplicating it through reverse engineering . Though excipients were at one time assumed to be "inactive" ingredients, it is now understood that they can sometimes be "a key determinant of dosage form performance"; in other words, their effects on pharmacodynamics and pharmacokinetics , although usually negligible, cannot be known to be negligible without empirical confirmation and sometimes are important. For that reason, in basic research and clinical trials they are sometimes included in

2652-559: The tablet punches or capsule filling machine. Lubricants also ensure that tablet formation and ejection can occur with low friction between the solid and die wall. Common minerals like talc or silica , and fats , e.g. vegetable stearin , magnesium stearate or stearic acid are the most frequently used lubricants in tablets or hard gelatin capsules. Lubricants are agents added in small quantities to tablet and capsule formulations to improve certain processing characteristics. While lubricants are often added to improve manufacturability of

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2704-412: Was created for drugs that may be significantly better treatments for serious diseases or conditions. On November 13, 2013, the FDA approved obinutuzumab (trade name Gazyva) by Hoffmann-La Roche for chronic lymphocytic leukemia making it the first drug to receive the breakthrough therapy designation. Title X revises requirements for notifying the FDA of drug shortages. It requires the FDA to establish

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